Difference between revisions of "Ovarian cancer"
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| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 5 IV over 1 hour once on day 1, '''given second''' | *[[Carboplatin (Paraplatin)]] AUC 5 IV over 1 hour once on day 1, '''given second''' | ||
| − | *[[Docetaxel (Taxotere)]] 75 mg/ | + | *[[Docetaxel (Taxotere)]] 75 mg/m<sup>2</sup> IV over 1 hour once on day 1, '''given first''' |
| − | Supportive medications | + | ====Supportive medications==== |
*[[Dexamethasone (Decadron)]] 8 mg PO BID the day before, the day of, and day after [[Docetaxel (Taxotere)]] | *[[Dexamethasone (Decadron)]] 8 mg PO BID the day before, the day of, and day after [[Docetaxel (Taxotere)]] | ||
*[[Ondansetron (Zofran)]] 8 mg or [[Granisetron (Kytril)]] 3 mg for [[antiemesis]] | *[[Ondansetron (Zofran)]] 8 mg or [[Granisetron (Kytril)]] 3 mg for [[antiemesis]] | ||
| − | '''21-day cycle | + | '''21-day cycle for 6 cycles''' |
===References=== | ===References=== | ||
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''Eligibility criteria for MITO-2 included: "a cytologic or histologic diagnosis of epithelial ovarian cancer (stage IC to IV according to International Federation of Gynecology and Obstetrics staging system).'' | ''Eligibility criteria for MITO-2 included: "a cytologic or histologic diagnosis of epithelial ovarian cancer (stage IC to IV according to International Federation of Gynecology and Obstetrics staging system).'' | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 5 IV over 30 minutes once on day 1, '''given first''' | *[[Carboplatin (Paraplatin)]] AUC 5 IV over 30 minutes once on day 1, '''given first''' | ||
| − | *[[Doxorubicin liposomal (Doxil)]] 30 mg/ | + | *[[Doxorubicin liposomal (Doxil)]] 30 mg/m<sup>2</sup> IV over 60 minutes once on day 1, '''given second''' |
| − | Supportive medications | + | ====Supportive medications==== |
*"No prophylactic use of G-CSF was recommended. Therapeutic and prophylactic use of G-CSF was allowed for febrile or afebrile grade 4 neutropenia." | *"No prophylactic use of G-CSF was recommended. Therapeutic and prophylactic use of G-CSF was allowed for febrile or afebrile grade 4 neutropenia." | ||
| − | '''21-day cycle | + | '''21-day cycle for 3 to 6 cycles''' |
''All patients received 3 cycles of therapy. Patients with stable or responsive disease received an additional 3 cycles.'' | ''All patients received 3 cycles of therapy. Patients with stable or responsive disease received an additional 3 cycles.'' | ||
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|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 5 IV over 30 minutes once on day 1, '''given second''' | *[[Carboplatin (Paraplatin)]] AUC 5 IV over 30 minutes once on day 1, '''given second''' | ||
| − | *[[Gemcitabine (Gemzar)]] 1000 mg/ | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV 30 minutes once per day on days 1 & 8, '''given first''' |
| − | '''21-day cycle | + | '''21-day cycle for up to 6 cycles''' |
''Patients with complete response could optionally proceed to receive [[Ovarian_cancer#Paclitaxel_.28Taxol.29|paclitaxel consolidation]].'' | ''Patients with complete response could optionally proceed to receive [[Ovarian_cancer#Paclitaxel_.28Taxol.29|paclitaxel consolidation]].'' | ||
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|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 7.5 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 7.5 IV once on day 1 | ||
| − | *[[Paclitaxel (Taxol)]] 175 mg/ | + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 3 hours once on day 1 |
| − | Supportive medications | + | ====Supportive medications==== |
*[[Dexamethasone (Decadron)]] 20 mg PO given twice, at 12 and 6 hours prior to chemotherapy OR 20 mg IV once 30 minutes prior to [[Paclitaxel (Taxol)]] | *[[Dexamethasone (Decadron)]] 20 mg PO given twice, at 12 and 6 hours prior to chemotherapy OR 20 mg IV once 30 minutes prior to [[Paclitaxel (Taxol)]] | ||
*[[Diphenhydramine (Benadryl)]] 50 mg IV once 30 minutes prior to [[Paclitaxel (Taxol)]] | *[[Diphenhydramine (Benadryl)]] 50 mg IV once 30 minutes prior to [[Paclitaxel (Taxol)]] | ||
*[[Cimetidine (Tagamet)]] 300 mg IV once 30 minutes prior to [[Paclitaxel (Taxol)]] | *[[Cimetidine (Tagamet)]] 300 mg IV once 30 minutes prior to [[Paclitaxel (Taxol)]] | ||
| − | '''21-day cycle | + | '''21-day cycle for 6 cycles''' |
===Regimen #2, AUC 5/175 {{#subobject:7ef902|Variant=1}}=== | ===Regimen #2, AUC 5/175 {{#subobject:7ef902|Variant=1}}=== | ||
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border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Carboplatin_.26_Docetaxel|Carboplatin & Docetaxel]] | |[[Ovarian_cancer#Carboplatin_.26_Docetaxel|Carboplatin & Docetaxel]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1553473/ Pignata et al. 2006 (MITO-2)] | |[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1553473/ Pignata et al. 2006 (MITO-2)] | ||
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|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 5 IV over 1 hour once on day 1, '''given second''' | *[[Carboplatin (Paraplatin)]] AUC 5 IV over 1 hour once on day 1, '''given second''' | ||
**Pignata et al. 2011 (MITO-2) gave carboplatin over 30 minutes | **Pignata et al. 2011 (MITO-2) gave carboplatin over 30 minutes | ||
| − | *[[Paclitaxel (Taxol)]] 175 mg/ | + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 3 hours once on day 1, '''given first''' |
Supportive medications (per Vasey et al. 2004): | Supportive medications (per Vasey et al. 2004): | ||
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*[[Ondansetron (Zofran)]] 8 mg or [[Granisetron (Kytril)]] 3 mg for [[antiemesis]] | *[[Ondansetron (Zofran)]] 8 mg or [[Granisetron (Kytril)]] 3 mg for [[antiemesis]] | ||
| − | '''21-day cycle | + | '''21-day cycle for 6 cycles''' |
''In MITO-2, all patients received 3 cycles of therapy. Patients with stable or responsive disease received an additional 3 cycles.'' | ''In MITO-2, all patients received 3 cycles of therapy. Patients with stable or responsive disease received an additional 3 cycles.'' | ||
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|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 6 IV over 1 hour once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 6 IV over 1 hour once on day 1 | ||
| − | *[[Paclitaxel (Taxol)]] 180 mg/ | + | *[[Paclitaxel (Taxol)]] 180 mg/m<sup>2</sup> IV over 3 hours once on day 1 |
| − | Supportive medications | + | ====Supportive medications==== |
*"Standard premedication" | *"Standard premedication" | ||
| − | '''21-day cycle | + | '''21-day cycle for 6 to 9 cycles, depending on response''' |
===Regimen #4, dose-dense paclitaxel {{#subobject:d2604f|Variant=1}}=== | ===Regimen #4, dose-dense paclitaxel {{#subobject:d2604f|Variant=1}}=== | ||
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|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 6 IV over 1 hour once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 6 IV over 1 hour once on day 1 | ||
| − | *[[Paclitaxel (Taxol)]] 80 mg/ | + | *[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV over 1 hour once per day on days 1, 8, 15 |
| − | Supportive medications | + | ====Supportive medications==== |
*"Standard premedication" | *"Standard premedication" | ||
| − | '''21-day cycle | + | '''21-day cycle for 6 to 9 cycles, depending on response''' |
===Regimen #5, AUC 6/175 {{#subobject:92b591|Variant=1}}=== | ===Regimen #5, AUC 6/175 {{#subobject:92b591|Variant=1}}=== | ||
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border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Carboplatin_.26_Gemcitabine|Carboplatin & Gemcitabine]] | |[[Ovarian_cancer#Carboplatin_.26_Gemcitabine|Carboplatin & Gemcitabine]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1104390 Burger et al. 2011 (GOG 218)] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa1104390 Burger et al. 2011 (GOG 218)] | ||
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border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Carboplatin.2C_Paclitaxel.2C_Bevacizumab|Carboplatin, Paclitaxel, Bevacizumab initiation]]<br> [[Ovarian_cancer#Carboplatin.2C_Paclitaxel.2C_Bevacizumab|Carboplatin, Paclitaxel, Bevacizumab throughout]] | |[[Ovarian_cancer#Carboplatin.2C_Paclitaxel.2C_Bevacizumab|Carboplatin, Paclitaxel, Bevacizumab initiation]]<br> [[Ovarian_cancer#Carboplatin.2C_Paclitaxel.2C_Bevacizumab|Carboplatin, Paclitaxel, Bevacizumab throughout]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1103799 Perren et al. 2011 (ICON7)] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa1103799 Perren et al. 2011 (ICON7)] | ||
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border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Carboplatin.2C_Paclitaxel.2C_Bevacizumab|Carboplatin, Paclitaxel, Bevacizumab]] | |[[Ovarian_cancer#Carboplatin.2C_Paclitaxel.2C_Bevacizumab|Carboplatin, Paclitaxel, Bevacizumab]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70049-X/abstract Pignata et al. 2014 (MITO-7)] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70049-X/abstract Pignata et al. 2014 (MITO-7)] | ||
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|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 6 IV over 30 minutes once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 6 IV over 30 minutes once on day 1 | ||
| − | *[[Paclitaxel (Taxol)]] 175 mg/ | + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 3 hours once on day 1 |
| − | '''21-day cycle | + | '''21-day cycle for up to 6 cycles''' |
''Patients with complete response in Gordon et al. 2011 could optionally proceed to receive [[Ovarian_cancer#Paclitaxel_.28Taxol.29|paclitaxel consolidation]].'' | ''Patients with complete response in Gordon et al. 2011 could optionally proceed to receive [[Ovarian_cancer#Paclitaxel_.28Taxol.29|paclitaxel consolidation]].'' | ||
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|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 2 IV once per week | *[[Carboplatin (Paraplatin)]] AUC 2 IV once per week | ||
| − | *[[Paclitaxel (Taxol)]] 60 mg/ | + | *[[Paclitaxel (Taxol)]] 60 mg/m<sup>2</sup> IV once per week |
'''18-week course''' | '''18-week course''' | ||
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|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 6 IV over 30 minutes once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 6 IV over 30 minutes once on day 1 | ||
| − | *[[Paclitaxel (Taxol)]] 175 mg/ | + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 3 hours once on day 1 |
*[[Bevacizumab (Avastin)]] as follows: | *[[Bevacizumab (Avastin)]] as follows: | ||
**Cycle 1: none | **Cycle 1: none | ||
**Cycles 2 to 6: 15 mg/kg IV once on day 1 | **Cycles 2 to 6: 15 mg/kg IV once on day 1 | ||
| − | '''21-day cycle | + | '''21-day cycle for 6 cycles, followed by:''' |
*[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | *[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | ||
| − | '''21-day cycle | + | '''21-day cycle for up to 16 cycles''' |
===Regimen #2 {{#subobject:be6ac3|Variant=1}}=== | ===Regimen #2 {{#subobject:be6ac3|Variant=1}}=== | ||
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|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 5 to 6 IV over 30 to 60 minutes once on day 1; the protocol linked from Perren et al. 2011 clarifies that the recommended dose was AUC 6, but that it could be adjusted "according to standard practice" | *[[Carboplatin (Paraplatin)]] AUC 5 to 6 IV over 30 to 60 minutes once on day 1; the protocol linked from Perren et al. 2011 clarifies that the recommended dose was AUC 6, but that it could be adjusted "according to standard practice" | ||
| − | *[[Paclitaxel (Taxol)]] 175 mg/ | + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 3 hours once on day 1 |
*[[Bevacizumab (Avastin)]] as follows: | *[[Bevacizumab (Avastin)]] as follows: | ||
**Cycle 1: not given if chemotherapy starts within 4 weeks of surgery. If >4 weeks after surgery: 7.5 mg/kg IV once on day 1 | **Cycle 1: not given if chemotherapy starts within 4 weeks of surgery. If >4 weeks after surgery: 7.5 mg/kg IV once on day 1 | ||
**Cycles 2 to 6: 7.5 mg/kg IV once on day 1 | **Cycles 2 to 6: 7.5 mg/kg IV once on day 1 | ||
| − | '''21-day cycle | + | '''21-day cycle for 6 cycles, followed by:''' |
*[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | *[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | ||
| − | '''21-day cycle | + | '''21-day cycle for 12 cycles''' |
===References=== | ===References=== | ||
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|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV at an infusion rate of 1 mg/min once on day 1 | ||
| + | *[[Paclitaxel (Taxol)]] 135 mg/m<sup>2</sup> IV continuous infusion over 24 hours once on day 1 | ||
| − | + | '''21-day cycle for 6 cycles''' | |
| − | |||
| − | |||
| − | '''21-day cycle | ||
Supportive medications (details vary depending on reference): | Supportive medications (details vary depending on reference): | ||
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|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Altretamine (Hexalen)]] 260 mg/ | + | *[[Altretamine (Hexalen)]] 260 mg/m<sup>2</sup> PO once per day on days 1 to 14 |
'''28-day cycles''' | '''28-day cycles''' | ||
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border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
| − | |Paclitaxel | + | |Paclitaxel for 12 cycles |
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 3 hours once on day 1 | ||
| − | + | '''28-day cycle for 3 cycles''' | |
| − | |||
| − | '''28-day | ||
===Regimen #2 {{#subobject:dff428|Variant=1}}=== | ===Regimen #2 {{#subobject:dff428|Variant=1}}=== | ||
| Line 520: | Line 512: | ||
border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
| − | |Paclitaxel | + | |Paclitaxel for 3 cycles |
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 3 hours once on day 1 | ||
| − | + | '''28-day cycle for 12 cycles''' | |
| − | |||
| − | '''28-day | ||
===Regimen #3 {{#subobject:b5e4cb|Variant=1}}=== | ===Regimen #3 {{#subobject:b5e4cb|Variant=1}}=== | ||
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|} | |} | ||
| − | ''Treatment preceded by [[Ovarian_cancer#Carboplatin_.26_Gemcitabine|carboplatin & gemcitabine]] x6 versus [[Ovarian_cancer#Carboplatin_.26_Paclitaxel|carboplatin & paclitaxel]] | + | ''Treatment preceded by [[Ovarian_cancer#Carboplatin_.26_Gemcitabine|carboplatin & gemcitabine]] x6 versus [[Ovarian_cancer#Carboplatin_.26_Paclitaxel|carboplatin & paclitaxel]] x 6.'' |
| + | ====Chemotherapy==== | ||
| + | *[[Paclitaxel (Taxol)]] 135 mg/m<sup>2</sup> IV once on day 1 | ||
| − | + | '''28-day cycle for up to 12 cycles''' | |
| − | |||
| − | '''28-day cycle | ||
===Regimen #4 {{#subobject:5bb98c|Variant=1}}=== | ===Regimen #4 {{#subobject:5bb98c|Variant=1}}=== | ||
| Line 565: | Line 557: | ||
''Treatment preceded by carboplatin, gemcitabine, paclitaxel x6.'' | ''Treatment preceded by carboplatin, gemcitabine, paclitaxel x6.'' | ||
| + | ====Chemotherapy==== | ||
| + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 1 hour once on day 1 | ||
| − | + | '''21-day cycle for 3 cycles''' | |
| − | |||
| − | '''21-day cycle | ||
===Regimen #5 {{#subobject:7d827f|Variant=1}}=== | ===Regimen #5 {{#subobject:7d827f|Variant=1}}=== | ||
| Line 586: | Line 578: | ||
''Treatment preceded by carboplatin, gemcitabine, paclitaxel x6.'' | ''Treatment preceded by carboplatin, gemcitabine, paclitaxel x6.'' | ||
| + | ====Chemotherapy==== | ||
| + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 1 hour once on day 1 | ||
| − | + | '''21-day cycle for 12 cycles''' | |
| − | |||
| − | '''21-day cycle | ||
===References=== | ===References=== | ||
# Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003 Jul 1;21(13):2460-5. [http://jco.ascopubs.org/content/21/13/2460.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/12829663 PubMed] | # Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003 Jul 1;21(13):2460-5. [http://jco.ascopubs.org/content/21/13/2460.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/12829663 PubMed] | ||
| − | ## '''Update:''' Markman M, Liu PY, Moon J, Monk BJ, Copeland L, Wilczynski S, Alberts D. Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/ | + | ## '''Update:''' Markman M, Liu PY, Moon J, Monk BJ, Copeland L, Wilczynski S, Alberts D. Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m<sup>2</sup>) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel: follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial. Gynecol Oncol. 2009 Aug;114(2):195-8. Epub 2009 May 17. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744303 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19447479 PubMed] |
# Micha JP, Goldstein BH, Mattison JA, Bader K, Graham C, Rettenmaier MA, Brown JV, Markman M. Experience with single-agent paclitaxel consolidation following primary chemotherapy with carboplatin, paclitaxel, and gemcitabine in advanced ovarian cancer. Gynecol Oncol. 2005 Jan;96(1):132-5. [http://www.sciencedirect.com/science/article/pii/S0090825804008091 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15589591 PubMed] | # Micha JP, Goldstein BH, Mattison JA, Bader K, Graham C, Rettenmaier MA, Brown JV, Markman M. Experience with single-agent paclitaxel consolidation following primary chemotherapy with carboplatin, paclitaxel, and gemcitabine in advanced ovarian cancer. Gynecol Oncol. 2005 Jan;96(1):132-5. [http://www.sciencedirect.com/science/article/pii/S0090825804008091 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15589591 PubMed] | ||
# '''Retrospective:''' Abaid LN, Goldstein BH, Micha JP, Rettenmaier MA, Brown JV 3rd, Markman M. Improved overall survival with 12 cycles of single-agent paclitaxel maintenance therapy following a complete response to induction chemotherapy in advanced ovarian carcinoma. Oncology. 2010;78(5-6):389-93. Epub 2010 Aug 27. [http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowAbstract&ArtikelNr=000320579&Ausgabe=254415&ProduktNr=223857 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20798562 PubMed] | # '''Retrospective:''' Abaid LN, Goldstein BH, Micha JP, Rettenmaier MA, Brown JV 3rd, Markman M. Improved overall survival with 12 cycles of single-agent paclitaxel maintenance therapy following a complete response to induction chemotherapy in advanced ovarian carcinoma. Oncology. 2010;78(5-6):389-93. Epub 2010 Aug 27. [http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowAbstract&ArtikelNr=000320579&Ausgabe=254415&ProduktNr=223857 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20798562 PubMed] | ||
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''Patients enrolled in AGO-OVAR16 had histologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, were FIGO II to IV, and no evidence of progression after surgery and at least 5 cycles of platinum-taxane chemotherapy.'' | ''Patients enrolled in AGO-OVAR16 had histologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, were FIGO II to IV, and no evidence of progression after surgery and at least 5 cycles of platinum-taxane chemotherapy.'' | ||
| + | ====Chemotherapy==== | ||
*[[Pazopanib (Votrient)]] 800 mg PO once per day | *[[Pazopanib (Votrient)]] 800 mg PO once per day | ||
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|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> intraperitoneal rapid infusion once on day 2 | ||
| + | *[[Paclitaxel (Taxol)]] 135 mg/m<sup>2</sup> IV continuous infusion over 24 hours once on day 1, then 60 mg/m<sup>2</sup> intraperitoneal rapid infusion once on day 8 | ||
| − | + | ====Supportive medications==== | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | Supportive medications | ||
*"Standard premedication" for paclitaxel | *"Standard premedication" for paclitaxel | ||
*"Hydration and [[antiemesis|antiemetic agents]]" before cisplatin | *"Hydration and [[antiemesis|antiemetic agents]]" before cisplatin | ||
*Intraperitoneal doses of cisplatin and paclitaxel are reconstituted in 2 liters of warm normal saline before infusion | *Intraperitoneal doses of cisplatin and paclitaxel are reconstituted in 2 liters of warm normal saline before infusion | ||
| + | |||
| + | '''21-day cycle for 6 cycles''' | ||
===Regimen #2 {{#subobject:de6946|Variant=1}}=== | ===Regimen #2 {{#subobject:de6946|Variant=1}}=== | ||
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|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> in 2 liters of normal saline, intraperitoneal rapid infusion once on day 2, with patient rolled onto 4 different positions every 15 minutes to evenly distribute cisplatin | ||
| + | *[[Paclitaxel (Taxol)]] 135 mg/m<sup>2</sup> IV continuous infusion over 24 hours once on day 1, then 60 mg/m<sup>2</sup> in 1 liter saline, intraperitoneal rapid infusion once on day 8 | ||
| − | + | ====Supportive medications==== | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | Supportive medications | ||
*Additional 1 liter normal saline to be infused immediately after intraperitoneal paclitaxel | *Additional 1 liter normal saline to be infused immediately after intraperitoneal paclitaxel | ||
*Supportive medications left to investigator discretion | *Supportive medications left to investigator discretion | ||
| + | |||
| + | '''21-day cycle for 6 cycles''' | ||
===References=== | ===References=== | ||
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border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Carboplatin_.26_Paclitaxel_2|Carboplatin & Paclitaxel]]<br> [[Ovarian_cancer#Cisplatin_.26_Paclitaxel_3|Cisplatin & Paclitaxel]] | |[[Ovarian_cancer#Carboplatin_.26_Paclitaxel_2|Carboplatin & Paclitaxel]]<br> [[Ovarian_cancer#Cisplatin_.26_Paclitaxel_3|Cisplatin & Paclitaxel]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://jco.ascopubs.org/content/24/29/4699.long Pfisterer et al. 2006] | |[http://jco.ascopubs.org/content/24/29/4699.long Pfisterer et al. 2006] | ||
| Line 751: | Line 742: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
*[[Carboplatin (Paraplatin)]] AUC 5 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 5 IV once on day 1 | ||
| − | '''21-day cycle | + | '''21-day cycle for 6 to 10 cycles''' |
===References=== | ===References=== | ||
| Line 778: | Line 770: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 5 IV over 30 to 60 minutes once on day 1, given second | *[[Carboplatin (Paraplatin)]] AUC 5 IV over 30 to 60 minutes once on day 1, given second | ||
| − | *[[Docetaxel (Taxotere)]] 75 mg/ | + | *[[Docetaxel (Taxotere)]] 75 mg/m<sup>2</sup> IV over 60 minutes once on day 1, given first |
| − | + | ====Supportive medications==== | |
| − | |||
| − | Supportive medications | ||
*[[Steroid conversions|Corticosteroids]] given twice, 12 hours and 30 minutes before docetaxel | *[[Steroid conversions|Corticosteroids]] given twice, 12 hours and 30 minutes before docetaxel | ||
*Prophylactic [[antiemesis|antiemetics]] with 5-HT3 antagonist | *Prophylactic [[antiemesis|antiemetics]] with 5-HT3 antagonist | ||
| + | |||
| + | '''21-day cycle for 6 cycles''' | ||
===Regimen #2 {{#subobject:bd8ef9|Variant=1}}=== | ===Regimen #2 {{#subobject:bd8ef9|Variant=1}}=== | ||
| Line 802: | Line 794: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 2 IV over 30 minutes once per day on days 1, 8, 15, given second | *[[Carboplatin (Paraplatin)]] AUC 2 IV over 30 minutes once per day on days 1, 8, 15, given second | ||
| − | *[[Docetaxel (Taxotere)]] 35 mg/ | + | *[[Docetaxel (Taxotere)]] 35 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15, given first |
| − | *Body surface area capped at 2 | + | *Body surface area capped at 2 m<sup>2</sup> |
| − | |||
| − | |||
| − | Supportive medications | + | ====Supportive medications==== |
*[[Dexamethasone (Decadron)]] 4 mg PO the evening before, the morning of, and evening after docetaxel | *[[Dexamethasone (Decadron)]] 4 mg PO the evening before, the morning of, and evening after docetaxel | ||
*[[Antiemesis|5-HT3 antagonist]] before chemotherapy | *[[Antiemesis|5-HT3 antagonist]] before chemotherapy | ||
*Phenothiazine or 5-HT3 antagonist as needed as an outpatient | *Phenothiazine or 5-HT3 antagonist as needed as an outpatient | ||
*Diphenhydramine (Benadryl) 50 mg IV once immediately prior to docetaxel | *Diphenhydramine (Benadryl) 50 mg IV once immediately prior to docetaxel | ||
| + | |||
| + | '''28-day cycle for 6 cycles''' | ||
===References=== | ===References=== | ||
| Line 842: | Line 834: | ||
CALYPSO: '''<u>Ca</u>'''e'''<u>ly</u>'''x (Pegylated liposomal doxorubicin) in '''<u>P</u>'''latinum '''<u>S</u>'''ensitive '''<u>O</u>'''varian patients | CALYPSO: '''<u>Ca</u>'''e'''<u>ly</u>'''x (Pegylated liposomal doxorubicin) in '''<u>P</u>'''latinum '''<u>S</u>'''ensitive '''<u>O</u>'''varian patients | ||
| + | ====Chemotherapy==== | ||
*[[Carboplatin (Paraplatin)]] AUC 5 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 5 IV once on day 1 | ||
| − | *[[Doxorubicin liposomal (Doxil)]] 30 mg/ | + | *[[Doxorubicin liposomal (Doxil)]] 30 mg/m<sup>2</sup> IV once on day 1 |
| − | + | ====Supportive medications==== | |
| + | *"[[antiemesis|Antiemetics]], including a serotonin antagonist and corticosteroid with 5-HT3 antagonist" | ||
| − | + | '''28-day cycle for 6 or more cycles, depending on response and toxicity''' | |
| − | |||
===References=== | ===References=== | ||
| Line 873: | Line 866: | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Carboplatin_.28Paraplatin.29|Carboplatin]] | |[[Ovarian_cancer#Carboplatin_.28Paraplatin.29|Carboplatin]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://jco.ascopubs.org/content/30/17/2039.long Aghajanian et al. 2012 (OCEANS)] | |[http://jco.ascopubs.org/content/30/17/2039.long Aghajanian et al. 2012 (OCEANS)] | ||
| Line 886: | Line 877: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 4 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 4 IV once on day 1 | ||
| − | *[[Gemcitabine (Gemzar)]] 1000 mg/ | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 |
| − | '''21-day cycle | + | '''21-day cycle for 6 to 10 cycles''' |
===References=== | ===References=== | ||
| Line 921: | Line 912: | ||
====Initial therapy==== | ====Initial therapy==== | ||
*[[Carboplatin (Paraplatin)]] AUC 4 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 4 IV once on day 1 | ||
| − | *[[Gemcitabine (Gemzar)]] 1000 mg/ | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 |
*[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1, '''given first''' | *[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1, '''given first''' | ||
| − | '''21-day cycle | + | '''21-day cycle for 6 to 10 cycles, based on response;''' after completing these cycles of carboplatin, gemcitabine, and bevacizumab, patients continue on bevacizumab maintenance until progression of disease or unacceptable toxicity |
====Bevacizumab maintenance==== | ====Bevacizumab maintenance==== | ||
| Line 954: | Line 945: | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Carboplatin_.28Paraplatin.29|Carboplatin]]<br> [[Ovarian_cancer#Cisplatin_.26_Paclitaxel_3|Cisplatin & Paclitaxel]] | |[[Ovarian_cancer#Carboplatin_.28Paraplatin.29|Carboplatin]]<br> [[Ovarian_cancer#Cisplatin_.26_Paclitaxel_3|Cisplatin & Paclitaxel]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://jco.ascopubs.org/content/28/20/3323.long Pujade-Lauraine et al. 2010 (CALYPSO)] | |[http://jco.ascopubs.org/content/28/20/3323.long Pujade-Lauraine et al. 2010 (CALYPSO)] | ||
| Line 965: | Line 954: | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Carboplatin_.26_Doxorubicin_liposomal_2|Carboplatin & Pegylated liposomal doxorubicin]] | |[[Ovarian_cancer#Carboplatin_.26_Doxorubicin_liposomal_2|Carboplatin & Pegylated liposomal doxorubicin]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)71135-0/abstract Oza et al. 2015] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)71135-0/abstract Oza et al. 2015] | ||
| Line 980: | Line 967: | ||
CALYPSO: '''<u>Ca</u>'''e'''<u>ly</u>'''x (Pegylated liposomal doxorubicin) in '''<u>P</u>'''latinum '''<u>S</u>'''ensitive '''<u>O</u>'''varian patients | CALYPSO: '''<u>Ca</u>'''e'''<u>ly</u>'''x (Pegylated liposomal doxorubicin) in '''<u>P</u>'''latinum '''<u>S</u>'''ensitive '''<u>O</u>'''varian patients | ||
| − | + | ====Chemotherapy==== | |
*[[Carboplatin (Paraplatin)]] AUC 5 to 6 IV once on day 1 | *[[Carboplatin (Paraplatin)]] AUC 5 to 6 IV once on day 1 | ||
| − | *[[Paclitaxel (Taxol)]] 175 to 185 mg/ | + | *[[Paclitaxel (Taxol)]] 175 to 185 mg/m<sup>2</sup> IV over 3 hours once on day 1 |
'''21-day cycles''' | '''21-day cycles''' | ||
| Line 1,015: | Line 1,002: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Cisplatin (Platinol)]] 30 mg/m<sup>2</sup> IV once per day on days 1 & 8, given second | ||
| + | *[[Gemcitabine (Gemzar)]] 750 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8, given first | ||
| − | + | ====Supportive medications==== | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | Supportive medications | ||
*[[Antiemesis|5-HT3 antagonists]] | *[[Antiemesis|5-HT3 antagonists]] | ||
*[[Steroid conversions|Corticosteroids]] | *[[Steroid conversions|Corticosteroids]] | ||
*Prochlorperazine | *Prochlorperazine | ||
*Magnesium supplementation with cisplatin | *Magnesium supplementation with cisplatin | ||
| + | |||
| + | '''21-day cycles''' | ||
===References=== | ===References=== | ||
| Line 1,051: | Line 1,038: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Cisplatin (Platinol)]] 50 mg/ | + | *[[Cisplatin (Platinol)]] 50 mg/m<sup>2</sup> IV once on day 1 |
| − | *[[Paclitaxel (Taxol)]] 175 mg/ | + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV over 3 hours once on day 1 |
'''21-day cycles''' | '''21-day cycles''' | ||
| Line 1,079: | Line 1,066: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Docetaxel (Taxotere)]] 100 mg/m<sup>2</sup> IV over 1 hour once on day 1 | ||
| − | + | ====Supportive medications==== | |
| − | |||
| − | |||
| − | |||
| − | Supportive medications | ||
*[[Dexamethasone (Decadron)]] 8 mg PO BID starting 24 hours before docetaxel, and continuing for 48 hours after docetaxel | *[[Dexamethasone (Decadron)]] 8 mg PO BID starting 24 hours before docetaxel, and continuing for 48 hours after docetaxel | ||
*Diphenhydramine (Benadryl) 50 mg IV immediately prior to paclitaxel | *Diphenhydramine (Benadryl) 50 mg IV immediately prior to paclitaxel | ||
*[[Antiemesis|Antiemetics]] as needed | *[[Antiemesis|Antiemetics]] as needed | ||
| + | |||
| + | '''21-day cycles''' | ||
===References=== | ===References=== | ||
| Line 1,111: | Line 1,098: | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Topotecan_.28Hycamtin.29|Topotecan]] | |[[Ovarian_cancer#Topotecan_.28Hycamtin.29|Topotecan]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://jco.ascopubs.org/content/25/19/2811.long Mutch et al. 2007] | |[http://jco.ascopubs.org/content/25/19/2811.long Mutch et al. 2007] | ||
| Line 1,124: | Line 1,109: | ||
|- | |- | ||
|} | |} | ||
| − | *[[Doxorubicin liposomal (Doxil)]] 50 mg/ | + | ====Chemotherapy==== |
| + | *[[Doxorubicin liposomal (Doxil)]] 50 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | ||
'''28-day cycles''' | '''28-day cycles''' | ||
| Line 1,142: | Line 1,128: | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Ovarian_cancer#Gemcitabine_.28Gemzar.29|Gemcitabine]] | |[[Ovarian_cancer#Gemcitabine_.28Gemzar.29|Gemcitabine]] | ||
| − | |||
| − | |||
|- | |- | ||
|[http://jco.ascopubs.org/content/32/13/1302.long Pujade-Lauraine et al. 2014 (AURELIA)] | |[http://jco.ascopubs.org/content/32/13/1302.long Pujade-Lauraine et al. 2014 (AURELIA)] | ||
| Line 1,155: | Line 1,139: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Doxorubicin liposomal (Doxil)]] 40 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | ||
| − | + | ====Supportive medications==== | |
| − | |||
| − | Supportive medications | ||
*[[Methylprednisolone (Solumedrol)]] 20 mg IV once 30 minutes prior to chemotherapy | *[[Methylprednisolone (Solumedrol)]] 20 mg IV once 30 minutes prior to chemotherapy | ||
| Line 1,192: | Line 1,176: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Doxorubicin liposomal (Doxil)]] 40 mg/ | + | *[[Doxorubicin liposomal (Doxil)]] 40 mg/m<sup>2</sup> IV once on day 1 |
*[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15 | *[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15 | ||
| Line 1,221: | Line 1,205: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Doxorubicin liposomal (Doxil)]] 30 mg/m<sup>2</sup> IV over 60 minutes once on day 1, given first | ||
| + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | ||
| − | + | ====Supportive medications==== | |
| − | * | + | *Metoclopramide (Reglan) before chemotherapy |
'''21-day cycles''' | '''21-day cycles''' | ||
| − | |||
| − | |||
| − | |||
===References=== | ===References=== | ||
| Line 1,252: | Line 1,236: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Etoposide (Vepesid)]] 50 mg/ | + | *[[Etoposide (Vepesid)]] 50 mg/m<sup>2</sup> PO once per day on days 1 to 21 |
| − | **Dosage for patients with previous pelvic radiation was Etoposide (Vepesid) 30 mg/ | + | **Dosage for patients with previous pelvic radiation was Etoposide (Vepesid) 30 mg/m<sup>2</sup> PO once per day on days 1 to 21; dose could be increased up to 50 mg/m<sup>2</sup> depending on toxicity |
'''28-day cycles''' | '''28-day cycles''' | ||
| Line 1,282: | Line 1,266: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Gemcitabine (Gemzar)]] 1000 mg/ | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 & 8 |
'''21-day cycles''' | '''21-day cycles''' | ||
| Line 1,303: | Line 1,287: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Gemcitabine (Gemzar)]] 1000 mg/ | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 |
'''28-day cycles''' | '''28-day cycles''' | ||
| Line 1,351: | Line 1,335: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Olaparib (Lynparza)]] 400 mg PO BID | *[[Olaparib (Lynparza)]] 400 mg PO BID | ||
| Line 1,371: | Line 1,355: | ||
|} | |} | ||
''These are ongoing phase III maintenance trials. This is not the FDA-approved dose.'' | ''These are ongoing phase III maintenance trials. This is not the FDA-approved dose.'' | ||
| − | + | ====Chemotherapy==== | |
*[[Olaparib (Lynparza)]] 300 mg PO BID | *[[Olaparib (Lynparza)]] 300 mg PO BID | ||
| Line 1,399: | Line 1,383: | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
| | | | ||
| − | |||
| − | |||
|- | |- | ||
|[http://jco.ascopubs.org/content/32/13/1302.long Pujade-Lauraine et al. 2014 (AURELIA)] | |[http://jco.ascopubs.org/content/32/13/1302.long Pujade-Lauraine et al. 2014 (AURELIA)] | ||
| Line 1,412: | Line 1,394: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV over 1 hour once per day on days 1, 8, 15, 22 | ||
| + | **Body surface area capped at 2 m<sup>2</sup> | ||
| − | + | ====Supportive medications==== | |
| − | |||
| − | |||
| − | Supportive medications | ||
*[[Dexamethasone (Decadron)]] 10 mg PO/IV once 30 to 60 minutes prior to [[Paclitaxel (Taxol)]] | *[[Dexamethasone (Decadron)]] 10 mg PO/IV once 30 to 60 minutes prior to [[Paclitaxel (Taxol)]] | ||
*[[Diphenhydramine (Benadryl)]] 25 to 50 mg IV once 30 to 60 minutes prior to [[Paclitaxel (Taxol)]] | *[[Diphenhydramine (Benadryl)]] 25 to 50 mg IV once 30 to 60 minutes prior to [[Paclitaxel (Taxol)]] | ||
| Line 1,424: | Line 1,406: | ||
===References=== | ===References=== | ||
| − | # Gynecologic Oncology Group, Markman M, Blessing J, Rubin SC, Connor J, Hanjani P, Waggoner S. Phase II trial of weekly paclitaxel (80 mg/ | + | # Gynecologic Oncology Group, Markman M, Blessing J, Rubin SC, Connor J, Hanjani P, Waggoner S. Phase II trial of weekly paclitaxel (80 mg/m<sup>2</sup>) in platinum and paclitaxel-resistant ovarian and primary peritoneal cancers: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Jun;101(3):436-40. Epub 2005 Dec 2. [http://www.gynecologiconcology-online.net/article/S0090-8258(05)00976-5/abstract link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16325893 PubMed] |
# Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. [http://jco.ascopubs.org/content/32/13/1302.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/24637997 PubMed] | # Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. [http://jco.ascopubs.org/content/32/13/1302.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/24637997 PubMed] | ||
## '''Update:''' Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. [http://jco.ascopubs.org/content/32/13/1309.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/24687829 PubMed] | ## '''Update:''' Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. [http://jco.ascopubs.org/content/32/13/1309.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/24687829 PubMed] | ||
| Line 1,449: | Line 1,431: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Paclitaxel (Taxol)]] 80 mg/ | + | *[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22 |
*[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15 | *[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15 | ||
| Line 1,478: | Line 1,460: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 260 mg/m<sup>2</sup> IV over 30 minutes once on day 1 | ||
| − | + | '''21-day cycle for 6 to 8 cycles''' | |
| − | |||
| − | '''21-day | ||
===References=== | ===References=== | ||
| Line 1,505: | Line 1,487: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
*[[Pazopanib (Votrient)]] 800 mg PO once per day | *[[Pazopanib (Votrient)]] 800 mg PO once per day | ||
| Line 1,532: | Line 1,514: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Pemetrexed (Alimta)]] 900 mg/m<sup>2</sup> IV over 10 minutes once on day 1 | ||
| + | **Dosage for patients with previous radiation therapy was [[Pemetrexed (Alimta)]] 700 mg/m<sup>2</sup> IV over 10 minutes once on day 1 | ||
| − | + | ====Supportive medications==== | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | Supportive medications | ||
*Folic acid 350 to 600 mcg PO once per day, starting 7 days before pemetrexed, to continue throughout therapy | *Folic acid 350 to 600 mcg PO once per day, starting 7 days before pemetrexed, to continue throughout therapy | ||
*[[Cyanocobalamin (Vitamin B12)]] 1000 mcg IM once 7 days before pemetrexed (then 1000 mcg to be given once every 9 weeks thereafter) | *[[Cyanocobalamin (Vitamin B12)]] 1000 mcg IM once 7 days before pemetrexed (then 1000 mcg to be given once every 9 weeks thereafter) | ||
*[[Dexamethasone (Decadron)]] 4 mg PO BID the day before, the day of, and day after Pemetrexed (Alimta) | *[[Dexamethasone (Decadron)]] 4 mg PO BID the day before, the day of, and day after Pemetrexed (Alimta) | ||
*No NSAIDs (nonsteroidal anti-inflammatory drugs) for 2 days before or after pemetrexed | *No NSAIDs (nonsteroidal anti-inflammatory drugs) for 2 days before or after pemetrexed | ||
| + | |||
| + | '''21-day cycles''' | ||
===References=== | ===References=== | ||
| Line 1,568: | Line 1,550: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Topotecan (Hycamtin)]] 1.5 mg/ | + | *[[Topotecan (Hycamtin)]] 1.5 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 5 |
'''21-day cycles''' | '''21-day cycles''' | ||
| Line 1,598: | Line 1,580: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Topotecan (Hycamtin)]] 1.25 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 5 | ||
| − | + | '''21-day cycle for up to 12 months'''; in AURELIA, topotecan was given until progression of disease or unacceptable toxicity | |
| − | |||
| − | '''21-day | ||
===Regimen #3, weekly dosing {{#subobject:a8bc04|Variant=1}}=== | ===Regimen #3, weekly dosing {{#subobject:a8bc04|Variant=1}}=== | ||
| Line 1,628: | Line 1,610: | ||
|- | |- | ||
|} | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Topotecan (Hycamtin)]] 4 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | ||
| − | + | '''28-day cycle for up to 12 months'''; in AURELIA, topotecan was given until progression of disease or unacceptable toxicity | |
| − | |||
| − | '''28-day | ||
===References=== | ===References=== | ||
| Line 1,661: | Line 1,643: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Topotecan (Hycamtin)]] 4 mg/ | + | *[[Topotecan (Hycamtin)]] 4 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 |
*[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15 | *[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15 | ||
| Line 1,683: | Line 1,665: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Topotecan (Hycamtin)]] 1.25 mg/ | + | *[[Topotecan (Hycamtin)]] 1.25 mg/m<sup>2</sup> IV once per day on days 1 to 5 |
*[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | *[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | ||
| Line 1,712: | Line 1,694: | ||
|- | |- | ||
|} | |} | ||
| − | + | ====Chemotherapy==== | |
| − | *[[Vinorelbine (Navelbine)]] 30 mg/ | + | *[[Vinorelbine (Navelbine)]] 30 mg/m<sup>2</sup> IV once per day on days 1 & 8 |
'''21-day cycles''' | '''21-day cycles''' | ||
Revision as of 01:22, 7 August 2016
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Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.
51 regimens on this page
98 variants on this page
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Primary chemotherapy for advanced/metastatic disease
Carboplatin & Docetaxel
| back to top |
Regimen
| Study | Evidence | Comparator |
| Vasey et al. 2004 | Phase III | Carboplatin & Paclitaxel |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV over 1 hour once on day 1, given second
- Docetaxel (Taxotere) 75 mg/m2 IV over 1 hour once on day 1, given first
Supportive medications
- Dexamethasone (Decadron) 8 mg PO BID the day before, the day of, and day after Docetaxel (Taxotere)
- Ondansetron (Zofran) 8 mg or Granisetron (Kytril) 3 mg for antiemesis
21-day cycle for 6 cycles
References
- Vasey PA, Jayson GC, Gordon A, Gabra H, Coleman R, Atkinson R, Parkin D, Paul J, Hay A, Kaye SB; Scottish Gynaecological Cancer Trials Group. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst. 2004 Nov 17;96(22):1682-91. link to original article contains verified protocol PubMed
Carboplatin & Doxorubicin liposomal
| back to top |
Regimen
| Study | Evidence | Comparator |
| Pignata et al. 2006 (MITO-2) | Phase III | Carboplatin & Paclitaxel |
Eligibility criteria for MITO-2 included: "a cytologic or histologic diagnosis of epithelial ovarian cancer (stage IC to IV according to International Federation of Gynecology and Obstetrics staging system).
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV over 30 minutes once on day 1, given first
- Doxorubicin liposomal (Doxil) 30 mg/m2 IV over 60 minutes once on day 1, given second
Supportive medications
- "No prophylactic use of G-CSF was recommended. Therapeutic and prophylactic use of G-CSF was allowed for febrile or afebrile grade 4 neutropenia."
21-day cycle for 3 to 6 cycles
All patients received 3 cycles of therapy. Patients with stable or responsive disease received an additional 3 cycles.
References
- Pignata S, Scambia G, Savarese A, Breda E, Scollo P, De Vivo R, Rossi E, Gebbia V, Natale D, Del Gaizo F, Naglieri E, Ferro A, Musso P, D'Arco AM, Sorio R, Pisano C, Di Maio M, Signoriello G, Annunziata A, Perrone F; MITO Investigators. Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial. BMC Cancer. 2006 Aug 1;6:202. link to PMC article contains verified protocol PubMed
- Update: Pignata S, Scambia G, Ferrandina G, Savarese A, Sorio R, Breda E, Gebbia V, Musso P, Frigerio L, Del Medico P, Lombardi AV, Febbraro A, Scollo P, Ferro A, Tamberi S, Brandes A, Ravaioli A, Valerio MR, Aitini E, Natale D, Scaltriti L, Greggi S, Pisano C, Lorusso D, Salutari V, Legge F, Di Maio M, Morabito A, Gallo C, Perrone F. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. J Clin Oncol. 2011 Sep 20;29(27):3628-35. Epub 2011 Aug 15. link to original article contains verified protocol PubMed
Carboplatin & Gemcitabine
| back to top |
Regimen
| Study | Evidence | Comparator |
| Gordon et al. 2011 | Phase III | Carboplatin & Paclitaxel |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV over 30 minutes once on day 1, given second
- Gemcitabine (Gemzar) 1000 mg/m2 IV 30 minutes once per day on days 1 & 8, given first
21-day cycle for up to 6 cycles
Patients with complete response could optionally proceed to receive paclitaxel consolidation.
References
- Gordon AN, Teneriello M, Janicek MF, Hines J, Lim PC, Chen MD, Vaccarello L, Homesley HD, McMeekin S, Burkholder TL, Wang Y, Zhao L, Orlando M, Obasaju CK, Gill JF, Tai DF. Phase III trial of induction gemcitabine or paclitaxel plus carboplatin followed by paclitaxel consolidation in ovarian cancer. Gynecol Oncol. 2011 Dec;123(3):479-85. Epub 2011 Oct 5. link to original article contains verified protocol PubMed
Carboplatin & Paclitaxel
| back to top |
Regimen #1, AUC 7.5/175
| Study | Evidence | Comparator |
| Ozols et al. 2003 (GOG 158) | Phase III | Cisplatin & Paclitaxel |
Chemotherapy
- Carboplatin (Paraplatin) AUC 7.5 IV once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1
Supportive medications
- Dexamethasone (Decadron) 20 mg PO given twice, at 12 and 6 hours prior to chemotherapy OR 20 mg IV once 30 minutes prior to Paclitaxel (Taxol)
- Diphenhydramine (Benadryl) 50 mg IV once 30 minutes prior to Paclitaxel (Taxol)
- Cimetidine (Tagamet) 300 mg IV once 30 minutes prior to Paclitaxel (Taxol)
21-day cycle for 6 cycles
Regimen #2, AUC 5/175
| Study | Evidence | Comparator |
| Vasey et al. 2004 | Phase III | Carboplatin & Docetaxel |
| Pignata et al. 2006 (MITO-2) | Phase III | Carboplatin & Pegylated liposomal doxorubicin |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV over 1 hour once on day 1, given second
- Pignata et al. 2011 (MITO-2) gave carboplatin over 30 minutes
- Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1, given first
Supportive medications (per Vasey et al. 2004):
- Dexamethasone (Decadron) 20 mg PO given twice, at 12 and 6 hours prior to Paclitaxel (Taxol)
- Diphenhydramine (Benadryl) 50 mg IV or Chlorpheniramine (Chlor-Trimeton) 10 mg IV once 30 minutes prior to Paclitaxel (Taxol)
- Ranitidine (Zantac) 50 mg IV or Cimetidine (Tagamet) 300 mg IV once 30 minutes prior to Paclitaxel (Taxol)
- Ondansetron (Zofran) 8 mg or Granisetron (Kytril) 3 mg for antiemesis
21-day cycle for 6 cycles
In MITO-2, all patients received 3 cycles of therapy. Patients with stable or responsive disease received an additional 3 cycles.
Regimen #3, AUC 6/180
| Study | Evidence | Comparator |
| Katsumata et al. 2009 | Phase III | Carboplatin & dose-dense Paclitaxel |
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV over 1 hour once on day 1
- Paclitaxel (Taxol) 180 mg/m2 IV over 3 hours once on day 1
Supportive medications
- "Standard premedication"
21-day cycle for 6 to 9 cycles, depending on response
Regimen #4, dose-dense paclitaxel
| Study | Evidence | Comparator |
| Katsumata et al. 2009 | Phase III | Carboplatin & Paclitaxel |
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV over 1 hour once on day 1
- Paclitaxel (Taxol) 80 mg/m2 IV over 1 hour once per day on days 1, 8, 15
Supportive medications
- "Standard premedication"
21-day cycle for 6 to 9 cycles, depending on response
Regimen #5, AUC 6/175
| Study | Evidence | Comparator |
| Gordon et al. 2011 | Phase III | Carboplatin & Gemcitabine |
| Burger et al. 2011 (GOG 218) | Phase III | Carboplatin, Paclitaxel, Bevacizumab initiation Carboplatin, Paclitaxel, Bevacizumab throughout |
| Perren et al. 2011 (ICON7) | Phase III | Carboplatin, Paclitaxel, Bevacizumab |
| Pignata et al. 2014 (MITO-7) | Phase III | Weekly Carboplatin & Paclitaxel |
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV over 30 minutes once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1
21-day cycle for up to 6 cycles
Patients with complete response in Gordon et al. 2011 could optionally proceed to receive paclitaxel consolidation.
Regimen #6, weekly carboplatin & paclitaxel
| Study | Evidence | Comparator |
| Pignata et al. 2014 (MITO-7) | Phase III | Carboplatin AUC 6 & Paclitaxel 175 |
Chemotherapy
- Carboplatin (Paraplatin) AUC 2 IV once per week
- Paclitaxel (Taxol) 60 mg/m2 IV once per week
18-week course
References
- Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. Epub 2003 Jul 14. link to original article contains verified protocol PubMed
- Vasey PA, Jayson GC, Gordon A, Gabra H, Coleman R, Atkinson R, Parkin D, Paul J, Hay A, Kaye SB; Scottish Gynaecological Cancer Trials Group. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst. 2004 Nov 17;96(22):1682-91. link to original article contains verified protocol PubMed
- Pignata S, Scambia G, Savarese A, Breda E, Scollo P, De Vivo R, Rossi E, Gebbia V, Natale D, Del Gaizo F, Naglieri E, Ferro A, Musso P, D'Arco AM, Sorio R, Pisano C, Di Maio M, Signoriello G, Annunziata A, Perrone F; MITO Investigators. Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial. BMC Cancer. 2006 Aug 1;6:202. link to PMC article contains verified protocol PubMed
- Update: Pignata S, Scambia G, Ferrandina G, Savarese A, Sorio R, Breda E, Gebbia V, Musso P, Frigerio L, Del Medico P, Lombardi AV, Febbraro A, Scollo P, Ferro A, Tamberi S, Brandes A, Ravaioli A, Valerio MR, Aitini E, Natale D, Scaltriti L, Greggi S, Pisano C, Lorusso D, Salutari V, Legge F, Di Maio M, Morabito A, Gallo C, Perrone F. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. J Clin Oncol. 2011 Sep 20;29(27):3628-35. Epub 2011 Aug 15. link to original article contains verified protocol PubMed
- Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. Epub 2009 Sep 18. link to original article contains verified protocol PubMed
- Gordon AN, Teneriello M, Janicek MF, Hines J, Lim PC, Chen MD, Vaccarello L, Homesley HD, McMeekin S, Burkholder TL, Wang Y, Zhao L, Orlando M, Obasaju CK, Gill JF, Tai DF. Phase III trial of induction gemcitabine or paclitaxel plus carboplatin followed by paclitaxel consolidation in ovarian cancer. Gynecol Oncol. 2011 Dec;123(3):479-85. Epub 2011 Oct 5. link to original article contains verified protocol PubMed
- Burger RA, Brady MF, Bookman MA, Fleming GF, Monk BJ, Huang H, Mannel RS, Homesley HD, Fowler J, Greer BE, Boente M, Birrer MJ, Liang SX; Gynecologic Oncology Group. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2473-83. link to original article contains verified protocol PubMed
- Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Kurzeder C, du Bois A, Sehouli J, Kimmig R, Stähle A, Collinson F, Essapen S, Gourley C, Lortholary A, Selle F, Mirza MR, Leminen A, Plante M, Stark D, Qian W, Parmar MK, Oza AM; ICON7 Investigators. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96. link to original article contains verified protocol PubMed
- Pignata S, Scambia G, Katsaros D, Gallo C, Pujade-Lauraine E, De Placido S, Bologna A, Weber B, Raspagliesi F, Panici PB, Cormio G, Sorio R, Cavazzini MG, Ferrandina G, Breda E, Murgia V, Sacco C, Cinieri S, Salutari V, Ricci C, Pisano C, Greggi S, Lauria R, Lorusso D, Marchetti C, Selvaggi L, Signoriello S, Piccirillo MC, Di Maio M, Perrone F; Multicentre Italian Trials in Ovarian cancer (MITO-7); Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (GINECO); Mario Negri Gynecologic Oncology (MaNGO); European Network of Gynaecological Oncological Trial Groups (ENGOT-OV-10); Gynecologic Cancer InterGroup (GCIG) Investigators. Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2014 Apr;15(4):396-405. Epub 2014 Feb 28. link to original article PubMed
Carboplatin, Paclitaxel, Bevacizumab
| back to top |
Regimen #1
| Study | Evidence | Comparator |
| Burger et al. 2011 (GOG 218) | Phase III | Carboplatin & Paclitaxel |
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV over 30 minutes once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1
- Bevacizumab (Avastin) as follows:
- Cycle 1: none
- Cycles 2 to 6: 15 mg/kg IV once on day 1
21-day cycle for 6 cycles, followed by:
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycle for up to 16 cycles
Regimen #2
| Study | Evidence | Comparator |
| Perren et al. 2011 (ICON7) | Phase III | Carboplatin & Paclitaxel |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 to 6 IV over 30 to 60 minutes once on day 1; the protocol linked from Perren et al. 2011 clarifies that the recommended dose was AUC 6, but that it could be adjusted "according to standard practice"
- Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1
- Bevacizumab (Avastin) as follows:
- Cycle 1: not given if chemotherapy starts within 4 weeks of surgery. If >4 weeks after surgery: 7.5 mg/kg IV once on day 1
- Cycles 2 to 6: 7.5 mg/kg IV once on day 1
21-day cycle for 6 cycles, followed by:
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycle for 12 cycles
References
- Burger RA, Brady MF, Bookman MA, Fleming GF, Monk BJ, Huang H, Mannel RS, Homesley HD, Fowler J, Greer BE, Boente M, Birrer MJ, Liang SX; Gynecologic Oncology Group. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2473-83. link to original article contains verified protocol PubMed
- Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Kurzeder C, du Bois A, Sehouli J, Kimmig R, Stähle A, Collinson F, Essapen S, Gourley C, Lortholary A, Selle F, Mirza MR, Leminen A, Plante M, Stark D, Qian W, Parmar MK, Oza AM; ICON7 Investigators. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96. link to original article contains verified protocol PubMed
Cisplatin & Paclitaxel
| back to top |
Regimen
| Study | Evidence | Comparator |
| Ozols et al. 2003 (GOG 158) | Phase III | Carboplatin & Paclitaxel |
| Armstrong et al. 2006 | Phase III | Intraperitoneal Cisplatin & Paclitaxel |
| Walker et al. 2006 | Phase III | Intraperitoneal Cisplatin & Paclitaxel |
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV at an infusion rate of 1 mg/min once on day 1
- Paclitaxel (Taxol) 135 mg/m2 IV continuous infusion over 24 hours once on day 1
21-day cycle for 6 cycles
Supportive medications (details vary depending on reference):
- Dexamethasone (Decadron) 20 mg PO given twice, at 12 and 6 hours prior to chemotherapy OR 20 mg IV once 30 minutes prior to paclitaxel
- Diphenhydramine (Benadryl) 50 mg IV once 30 minutes prior to paclitaxel
- Cimetidine (Tagamet) 300 mg IV once 30 minutes prior to paclitaxel
- "Hydration and antiemetic agents" before cisplatin
References
- Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. Epub 2003 Jul 14. link to original article contains verified protocol PubMed
- Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. link to original article contains verified protocol PubMed
- Walker JL, Armstrong DK, Huang HQ, Fowler J, Webster K, Burger RA, Clarke-Pearson D. Intraperitoneal catheter outcomes in a phase III trial of intravenous versus intraperitoneal chemotherapy in optimal stage III ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 2006 Jan;100(1):27-32. link to original article contains verified protocol PubMed
Maintenance/consolidation therapy
Altretamine (Hexalen)
| back to top |
Regimen
| Study | Evidence |
| Alberts et al. 2004 | Phase II |
Chemotherapy
- Altretamine (Hexalen) 260 mg/m2 PO once per day on days 1 to 14
28-day cycles
References
- Alberts DS, Jiang C, Liu PY, Wilczynski S, Markman M, Rothenberg ML. Long-term follow-up of a phase II trial of oral altretamine for consolidation of clinical complete remission in women with stage III epithelial ovarian cancer in the Southwest Oncology Group. Int J Gynecol Cancer. 2004 Mar-Apr;14(2):224-8. PubMed
Paclitaxel (Taxol)
| back to top |
Regimen #1
| Study | Evidence | Comparator |
| Markman et al. 2003 (GOG 178) | Phase III | Paclitaxel for 12 cycles |
Chemotherapy
- Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1
28-day cycle for 3 cycles
Regimen #2
| Study | Evidence | Comparator |
| Markman et al. 2003 (GOG 178) | Phase III | Paclitaxel for 3 cycles |
Chemotherapy
- Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1
28-day cycle for 12 cycles
Regimen #3
| Study | Evidence |
| Gordon et al. 2011 | Non-randomized |
Treatment preceded by carboplatin & gemcitabine x6 versus carboplatin & paclitaxel x 6.
Chemotherapy
- Paclitaxel (Taxol) 135 mg/m2 IV once on day 1
28-day cycle for up to 12 cycles
Regimen #4
| Study | Evidence |
| Micha et al. 2005 | Phase II, <20 patients in this subgroup |
Treatment preceded by carboplatin, gemcitabine, paclitaxel x6.
Chemotherapy
- Paclitaxel (Taxol) 175 mg/m2 IV over 1 hour once on day 1
21-day cycle for 3 cycles
Regimen #5
| Study | Evidence |
| Micha et al. 2005 | Phase II, <20 patients in this subgroup |
Treatment preceded by carboplatin, gemcitabine, paclitaxel x6.
Chemotherapy
- Paclitaxel (Taxol) 175 mg/m2 IV over 1 hour once on day 1
21-day cycle for 12 cycles
References
- Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003 Jul 1;21(13):2460-5. link to original article contains verified protocol PubMed
- Update: Markman M, Liu PY, Moon J, Monk BJ, Copeland L, Wilczynski S, Alberts D. Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m2) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel: follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial. Gynecol Oncol. 2009 Aug;114(2):195-8. Epub 2009 May 17. link to original article contains verified protocol PubMed
- Micha JP, Goldstein BH, Mattison JA, Bader K, Graham C, Rettenmaier MA, Brown JV, Markman M. Experience with single-agent paclitaxel consolidation following primary chemotherapy with carboplatin, paclitaxel, and gemcitabine in advanced ovarian cancer. Gynecol Oncol. 2005 Jan;96(1):132-5. link to original article contains verified protocol PubMed
- Retrospective: Abaid LN, Goldstein BH, Micha JP, Rettenmaier MA, Brown JV 3rd, Markman M. Improved overall survival with 12 cycles of single-agent paclitaxel maintenance therapy following a complete response to induction chemotherapy in advanced ovarian carcinoma. Oncology. 2010;78(5-6):389-93. Epub 2010 Aug 27. link to original article contains verified protocol PubMed
- Gordon AN, Teneriello M, Janicek MF, Hines J, Lim PC, Chen MD, Vaccarello L, Homesley HD, McMeekin S, Burkholder TL, Wang Y, Zhao L, Orlando M, Obasaju CK, Gill JF, Tai DF. Phase III trial of induction gemcitabine or paclitaxel plus carboplatin followed by paclitaxel consolidation in ovarian cancer. Gynecol Oncol. 2011 Dec;123(3):479-85. Epub 2011 Oct 5. link to original article contains verified protocol PubMed
Pazopanib (Votrient)
| back to top |
Regimen
| Study | Evidence | Comparator |
| Du Bois et al. 2013 (AGO-OVAR16) | Phase III | Placebo |
Patients enrolled in AGO-OVAR16 had histologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, were FIGO II to IV, and no evidence of progression after surgery and at least 5 cycles of platinum-taxane chemotherapy.
Chemotherapy
- Pazopanib (Votrient) 800 mg PO once per day
24-month course
References
- Abstract: Andreas Du Bois, Anne Floquet, Jae Weon Kim, Jörn Rau, Jose Maria Del Campo, Michael Friedlander, Sandro Pignata, Keiichi Fujiwara, Ignace Vergote, Nicoletta Colombo, Mansoor Raza Mirza, Bradley J. Monk, Pauline Wimberger, Isabelle Ray-Coquard, Rongyu Zang, Ivan Diaz-Padilla, Klaus H. Baumann, Jae Hoon Kim, Philipp Harter. Randomized, double-blind, phase III trial of pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (AEOC): Results of an international Intergroup trial (AGO-OVAR16). 2013 ASCO Annual Meeting abstract LBA5503. link to abstract
Placebo
| back to top |
Regimen
| Study | Evidence | Comparator |
| Du Bois et al. 2013 (AGO-OVAR16) | Phase III | Pazopanib |
No treatment after initial platinum-taxane treatment. Used as a comparator arm and here for reference purposes only.
References
- Abstract: Andreas Du Bois, Anne Floquet, Jae Weon Kim, Jörn Rau, Jose Maria Del Campo, Michael Friedlander, Sandro Pignata, Keiichi Fujiwara, Ignace Vergote, Nicoletta Colombo, Mansoor Raza Mirza, Bradley J. Monk, Pauline Wimberger, Isabelle Ray-Coquard, Rongyu Zang, Ivan Diaz-Padilla, Klaus H. Baumann, Jae Hoon Kim, Philipp Harter. Randomized, double-blind, phase III trial of pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (AEOC): Results of an international Intergroup trial (AGO-OVAR16). 2013 ASCO Annual Meeting abstract LBA5503. link to abstract
Intraperitoneal therapy
Cisplatin & Paclitaxel
| back to top |
Regimen #1
| Study | Evidence | Comparator |
| Armstrong et al. 2006 | Phase III | Cisplatin & Paclitaxel |
Chemotherapy
- Cisplatin (Platinol) 100 mg/m2 intraperitoneal rapid infusion once on day 2
- Paclitaxel (Taxol) 135 mg/m2 IV continuous infusion over 24 hours once on day 1, then 60 mg/m2 intraperitoneal rapid infusion once on day 8
Supportive medications
- "Standard premedication" for paclitaxel
- "Hydration and antiemetic agents" before cisplatin
- Intraperitoneal doses of cisplatin and paclitaxel are reconstituted in 2 liters of warm normal saline before infusion
21-day cycle for 6 cycles
Regimen #2
| Study | Evidence | Comparator |
| Walker et al. 2006 | Phase III | Cisplatin & Paclitaxel |
Chemotherapy
- Cisplatin (Platinol) 100 mg/m2 in 2 liters of normal saline, intraperitoneal rapid infusion once on day 2, with patient rolled onto 4 different positions every 15 minutes to evenly distribute cisplatin
- Paclitaxel (Taxol) 135 mg/m2 IV continuous infusion over 24 hours once on day 1, then 60 mg/m2 in 1 liter saline, intraperitoneal rapid infusion once on day 8
Supportive medications
- Additional 1 liter normal saline to be infused immediately after intraperitoneal paclitaxel
- Supportive medications left to investigator discretion
21-day cycle for 6 cycles
References
- Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. link to original article contains verified protocol PubMed
- Walker JL, Armstrong DK, Huang HQ, Fowler J, Webster K, Burger RA, Clarke-Pearson D. Intraperitoneal catheter outcomes in a phase III trial of intravenous versus intraperitoneal chemotherapy in optimal stage III ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 2006 Jan;100(1):27-32. link to original article contains verified protocol PubMed
Relapsed or recurrent disease
Carboplatin (Paraplatin)
| back to top |
Regimen
| Study | Evidence | Comparator |
| Parmar et al. 2003 (ICON4/AGO-OVAR-2.2) | Phase III | Carboplatin & Paclitaxel Cisplatin & Paclitaxel |
| Pfisterer et al. 2006 | Phase III | Carboplatin & Gemcitabine |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV once on day 1
21-day cycle for 6 to 10 cycles
References
- Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Tropé C; ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003 Jun 21;361(9375):2099-106. link to original article contains verified protocol PubMed
- Pfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, Wagner U, Stähle A, Stuart G, Kimmig R, Olbricht S, Le T, Emerich J, Kuhn W, Bentley J, Jackisch C, Lück HJ, Rochon J, Zimmermann AH, Eisenhauer E; AGO-OVAR; NCIC CTG; EORTC GCG. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol. 2006 Oct 10;24(29):4699-707. Epub 2006 Sep 11. link to original article contains verified protocol PubMed
Carboplatin & Docetaxel
| back to top |
Regimen #1
| Study | Evidence |
| Strauss et al. 2007 | Phase II |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV over 30 to 60 minutes once on day 1, given second
- Docetaxel (Taxotere) 75 mg/m2 IV over 60 minutes once on day 1, given first
Supportive medications
- Corticosteroids given twice, 12 hours and 30 minutes before docetaxel
- Prophylactic antiemetics with 5-HT3 antagonist
21-day cycle for 6 cycles
Regimen #2
| Study | Evidence |
| Kushner et al. 2007 | Phase II |
Chemotherapy
- Carboplatin (Paraplatin) AUC 2 IV over 30 minutes once per day on days 1, 8, 15, given second
- Docetaxel (Taxotere) 35 mg/m2 IV over 60 minutes once per day on days 1, 8, 15, given first
- Body surface area capped at 2 m2
Supportive medications
- Dexamethasone (Decadron) 4 mg PO the evening before, the morning of, and evening after docetaxel
- 5-HT3 antagonist before chemotherapy
- Phenothiazine or 5-HT3 antagonist as needed as an outpatient
- Diphenhydramine (Benadryl) 50 mg IV once immediately prior to docetaxel
28-day cycle for 6 cycles
References
- Strauss HG, Henze A, Teichmann A, Karbe I, Baumgart A, Thomssen C, Koelbl H. Phase II trial of docetaxel and carboplatin in recurrent platinum-sensitive ovarian, peritoneal and tubal cancer. Gynecol Oncol. 2007 Mar;104(3):612-6. Epub 2006 Oct 27. link to original article contains verified protocol PubMed
- Kushner DM, Connor JP, Sanchez F, Volk M, Schink JC, Bailey HH, Harris LS, Stewart SL, Fine J, Hartenbach EM; Wisconsin Oncology Network. Weekly docetaxel and carboplatin for recurrent ovarian and peritoneal cancer: a phase II trial. Gynecol Oncol. 2007 May;105(2):358-64. Epub 2007 Jan 29. link to original article contains verified protocol PubMed
Carboplatin & Doxorubicin liposomal
| back to top |
Regimen
| Study | Evidence | Comparator |
| Pujade-Lauraine et al. 2010 (CALYPSO) | Phase III | Carboplatin & Paclitaxel |
CALYPSO: Caelyx (Pegylated liposomal doxorubicin) in Platinum Sensitive Ovarian patients
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV once on day 1
- Doxorubicin liposomal (Doxil) 30 mg/m2 IV once on day 1
Supportive medications
- "Antiemetics, including a serotonin antagonist and corticosteroid with 5-HT3 antagonist"
28-day cycle for 6 or more cycles, depending on response and toxicity
References
- Pujade-Lauraine E, Wagner U, Aavall-Lundqvist E, Gebski V, Heywood M, Vasey PA, Volgger B, Vergote I, Pignata S, Ferrero A, Sehouli J, Lortholary A, Kristensen G, Jackisch C, Joly F, Brown C, Le Fur N, du Bois A. Pegylated liposomal Doxorubicin and Carboplatin compared with Paclitaxel and Carboplatin for patients with platinum-sensitive ovarian cancer in late relapse. J Clin Oncol. 2010 Jul 10;28(20):3323-9. Epub 2010 May 24. link to original article contains verified protocol PubMed
- Update: Wagner U, Marth C, Largillier R, Kaern J, Brown C, Heywood M, Bonaventura T, Vergote I, Piccirillo MC, Fossati R, Gebski V, Lauraine EP. Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients. Br J Cancer. 2012 Aug 7;107(4):588-91. Epub 2012 Jul 26. link to original article contains verified protocol PubMed
Carboplatin & Gemcitabine
| back to top |
Regimen
| Study | Evidence | Comparator |
| Pfisterer et al. 2006 | Phase III | Carboplatin |
| Aghajanian et al. 2012 (OCEANS) | Phase III | Carboplatin, Gemcitabine, Bevacizumab |
Chemotherapy
- Carboplatin (Paraplatin) AUC 4 IV once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
21-day cycle for 6 to 10 cycles
References
- Pfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, Wagner U, Stähle A, Stuart G, Kimmig R, Olbricht S, Le T, Emerich J, Kuhn W, Bentley J, Jackisch C, Lück HJ, Rochon J, Zimmermann AH, Eisenhauer E; AGO-OVAR; NCIC CTG; EORTC GCG. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol. 2006 Oct 10;24(29):4699-707. Epub 2006 Sep 11. link to original article contains verified protocol PubMed
- Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, Husain A, Sovak MA, Yi J, Nycum LR. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012 Jun 10;30(17):2039-45. Epub 2012 Apr 23. link to original article contains verified protocol PubMed
- Update: Aghajanian C, Goff B, Nycum LR, Wang YV, Husain A, Blank SV. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol. 2015 Oct;139(1):10-6. Epub 2015 Aug 10. link to original article PubMed
Carboplatin, Gemcitabine, Bevacizumab
| back to top |
Regimen
| Study | Evidence | Comparator |
| Aghajanian et al. 2012 (OCEANS) | Phase III | Carboplatin & Gemcitabine |
Initial therapy
- Carboplatin (Paraplatin) AUC 4 IV once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1, given first
21-day cycle for 6 to 10 cycles, based on response; after completing these cycles of carboplatin, gemcitabine, and bevacizumab, patients continue on bevacizumab maintenance until progression of disease or unacceptable toxicity
Bevacizumab maintenance
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycles, given until progression of disease or unacceptable toxicity
References
- Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, Husain A, Sovak MA, Yi J, Nycum LR. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012 Jun 10;30(17):2039-45. Epub 2012 Apr 23. link to original article contains verified protocol PubMed
- Update: Aghajanian C, Goff B, Nycum LR, Wang YV, Husain A, Blank SV. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol. 2015 Oct;139(1):10-6. Epub 2015 Aug 10. link to original article PubMed
Carboplatin & Paclitaxel
| back to top |
Regimen
| Study | Evidence | Comparator |
| Parmar et al. 2003 (ICON4/AGO-OVAR-2.2) | Phase III | Carboplatin Cisplatin & Paclitaxel |
| Pujade-Lauraine et al. 2010 (CALYPSO) | Phase III | Carboplatin & Pegylated liposomal doxorubicin |
| Oza et al. 2015 | Randomized Phase II | Carboplatin, Paclitaxel, Olaparib |
CALYPSO: Caelyx (Pegylated liposomal doxorubicin) in Platinum Sensitive Ovarian patients
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 to 6 IV once on day 1
- Paclitaxel (Taxol) 175 to 185 mg/m2 IV over 3 hours once on day 1
21-day cycles
Supportive medications (varies depending on reference):
- Corticosteroids and prophylactic antiemetics with 5-HT3 antagonist
- Premedication (with steroids & antihistamines) prior to paclitaxel
References
- Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Tropé C; ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003 Jun 21;361(9375):2099-106. link to original article contains verified protocol PubMed
- Pujade-Lauraine E, Wagner U, Aavall-Lundqvist E, Gebski V, Heywood M, Vasey PA, Volgger B, Vergote I, Pignata S, Ferrero A, Sehouli J, Lortholary A, Kristensen G, Jackisch C, Joly F, Brown C, Le Fur N, du Bois A. Pegylated liposomal Doxorubicin and Carboplatin compared with Paclitaxel and Carboplatin for patients with platinum-sensitive ovarian cancer in late relapse. J Clin Oncol. 2010 Jul 10;28(20):3323-9. Epub 2010 May 24. link to original article contains verified protocol PubMed
- Update: Wagner U, Marth C, Largillier R, Kaern J, Brown C, Heywood M, Bonaventura T, Vergote I, Piccirillo MC, Fossati R, Gebski V, Lauraine EP. Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients. Br J Cancer. 2012 Aug 7;107(4):588-91. Epub 2012 Jul 26. link to original article contains verified protocol PubMed
- Oza AM, Cibula D, Benzaquen AO, Poole C, Mathijssen RH, Sonke GS, Colombo N, Špaček J, Vuylsteke P, Hirte H, Mahner S, Plante M, Schmalfeldt B, Mackay H, Rowbottom J, Lowe ES, Dougherty B, Barrett JC, Friedlander M. Olaparib combined with chemotherapy for recurrent platinum-sensitive ovarian cancer: a randomised phase 2 trial. Lancet Oncol. 2015 Jan;16(1):87-97. Epub 2014 Dec 4. Erratum in: Lancet Oncol. 2015 Feb;16(2):e55. Lancet Oncol. 2015 Jan;16(1):e6. link to original article PubMed
Cisplatin & Gemcitabine
| back to top |
Regimen
| Study | Evidence |
| Rose et al. 2003 | Phase II |
Chemotherapy
- Cisplatin (Platinol) 30 mg/m2 IV once per day on days 1 & 8, given second
- Gemcitabine (Gemzar) 750 mg/m2 IV over 30 minutes once per day on days 1 & 8, given first
Supportive medications
- 5-HT3 antagonists
- Corticosteroids
- Prochlorperazine
- Magnesium supplementation with cisplatin
21-day cycles
References
- Rose PG, Mossbruger K, Fusco N, Smrekar M, Eaton S, Rodriguez M. Gemcitabine reverses cisplatin resistance: demonstration of activity in platinum- and multidrug-resistant ovarian and peritoneal carcinoma. Gynecol Oncol. 2003 Jan;88(1):17-21. link to original article contains verified protocol PubMed
Cisplatin & Paclitaxel
| back to top |
Regimen
| Study | Evidence | Comparator |
| Parmar et al. 2003 (ICON4/AGO-OVAR-2.2) | Phase III | Carboplatin Carboplatin & Paclitaxel |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1
21-day cycles
References
- Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Tropé C; ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003 Jun 21;361(9375):2099-106. link to original article contains verified protocol PubMed
Docetaxel (Taxotere)
| back to top |
Regimen
| Study | Evidence |
| Rose et al. 2003 | Phase II |
Chemotherapy
- Docetaxel (Taxotere) 100 mg/m2 IV over 1 hour once on day 1
Supportive medications
- Dexamethasone (Decadron) 8 mg PO BID starting 24 hours before docetaxel, and continuing for 48 hours after docetaxel
- Diphenhydramine (Benadryl) 50 mg IV immediately prior to paclitaxel
- Antiemetics as needed
21-day cycles
References
- Rose PG, Blessing JA, Ball HG, Hoffman J, Warshal D, DeGeest K, Moore DH. A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2003 Feb;88(2):130-5. link to original article contains verified protocol PubMed
Doxorubicin liposomal (Doxil)
| back to top |
Regimen #1
| Study | Evidence | Comparator |
| Gordon et al. 2001 | Phase III | Topotecan |
| Mutch et al. 2007 | Phase III | Gemcitabine |
Chemotherapy
- Doxorubicin liposomal (Doxil) 50 mg/m2 IV over 60 minutes once on day 1
28-day cycles
Regimen #2
| Study | Evidence | Comparator |
| Ferrandina et al. 2008 | Phase III | Gemcitabine |
| Pujade-Lauraine et al. 2014 (AURELIA) | Phase III | Pegylated liposomal doxorubicin & Bevacizumab |
Chemotherapy
- Doxorubicin liposomal (Doxil) 40 mg/m2 IV over 60 minutes once on day 1
Supportive medications
- Methylprednisolone (Solumedrol) 20 mg IV once 30 minutes prior to chemotherapy
28-day cycles
References
- Gordon AN, Fleagle JT, Guthrie D, Parkin DE, Gore ME, Lacave AJ. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol. 2001 Jul 15;19(14):3312-22. link to original article PubMed
- Update: Gordon AN, Tonda M, Sun S, Rackoff W; Doxil Study 30-49 Investigators. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol. 2004 Oct;95(1):1-8. link to original article contains verified protocol PubMed
- Mutch DG, Orlando M, Goss T, Teneriello MG, Gordon AN, McMeekin SD, Wang Y, Scribner DR Jr, Marciniack M, Naumann RW, Secord AA. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol. 2007 Jul 1;25(19):2811-8. link to original article contains verified protocol PubMed content property of HemOnc.org
- Ferrandina G, Ludovisi M, Lorusso D, Pignata S, Breda E, Savarese A, Del Medico P, Scaltriti L, Katsaros D, Priolo D, Scambia G. Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer. J Clin Oncol. 2008 Feb 20;26(6):890-6. link to original article contains verified protocol PubMed
- Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. link to original article contains verified protocol PubMed
- Subgroup analysis: Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. link to original article PubMed
Doxorubicin liposomal & Bevacizumab
| back to top |
Regimen
| Study | Evidence | Comparator |
| Pujade-Lauraine et al. 2014 (AURELIA) | Phase III | Pegylated liposomal doxorubicin |
Chemotherapy
- Doxorubicin liposomal (Doxil) 40 mg/m2 IV once on day 1
- Bevacizumab (Avastin) 10 mg/kg IV once per day on days 1 & 15
28-day cycles, given until progression of disease or unacceptable toxicity
References
- Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. link to original article contains verified protocol PubMed
- Subgroup analysis: Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. link to original article PubMed
Doxorubicin liposomal & Gemcitabine
| back to top |
Regimen
| Study | Evidence |
| Ferrandina et al. 2005 | Phase II |
Chemotherapy
- Doxorubicin liposomal (Doxil) 30 mg/m2 IV over 60 minutes once on day 1, given first
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1 & 8
Supportive medications
- Metoclopramide (Reglan) before chemotherapy
21-day cycles
References
- Ferrandina G, Paris I, Ludovisi M, D'Agostino G, Testa A, Lorusso D, Zanghi M, Pisconti S, Pezzella G, Adamo V, Breda E, Scambia G. Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer: updated results and long-term survival. Gynecol Oncol. 2005 Aug;98(2):267-73. link to original article contains verified protocol PubMed
Etoposide (Vepesid)
| back to top |
Regimen
| Study | Evidence |
| Rose et al. 1998 | Phase II |
Chemotherapy
- Etoposide (Vepesid) 50 mg/m2 PO once per day on days 1 to 21
- Dosage for patients with previous pelvic radiation was Etoposide (Vepesid) 30 mg/m2 PO once per day on days 1 to 21; dose could be increased up to 50 mg/m2 depending on toxicity
28-day cycles
References
- Rose PG, Blessing JA, Mayer AR, Homesley HD. Prolonged oral etoposide as second-line therapy for platinum-resistant and platinum-sensitive ovarian carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 1998 Feb;16(2):405-10. link to original article contains verified protocol PubMed
Gemcitabine (Gemzar)
| back to top |
Regimen #1
| Study | Evidence | Comparator |
| Mutch et al. 2007 | Phase III | Pegylated liposomal doxorubicin |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 to 60 minutes once per day on days 1 & 8
21-day cycles
Regimen #2
| Study | Evidence | Comparator |
| Ferrandina et al. 2008 | Phase III | Pegylated liposomal doxorubicin |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
28-day cycles
References
- Mutch DG, Orlando M, Goss T, Teneriello MG, Gordon AN, McMeekin SD, Wang Y, Scribner DR Jr, Marciniack M, Naumann RW, Secord AA. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol. 2007 Jul 1;25(19):2811-8. link to original article contains verified protocol PubMed
- Ferrandina G, Ludovisi M, Lorusso D, Pignata S, Breda E, Savarese A, Del Medico P, Scaltriti L, Katsaros D, Priolo D, Scambia G. Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer. J Clin Oncol. 2008 Feb 20;26(6):890-6. link to original article contains verified protocol PubMed
Olaparib (Lynparza)
| back to top |
Regimen #1
| Study | Evidence | Comparator |
| Audeh et al. 2010 | Phase II | |
| Gelmon et al. 2011 | Phase II | |
| Ledermann et al. 2012 | Randomized Phase II | Placebo |
Chemotherapy
- Olaparib (Lynparza) 400 mg PO BID
Regimen #2
| Study | Evidence | Comparator |
| Moore et al. 2014 (SOLO1 & SOLO2) | Phase III | Placebo |
These are ongoing phase III maintenance trials. This is not the FDA-approved dose.
Chemotherapy
- Olaparib (Lynparza) 300 mg PO BID
References
- Audeh MW, Carmichael J, Penson RT, Friedlander M, Powell B, Bell-McGuinn KM, Scott C, Weitzel JN, Oaknin A, Loman N, Lu K, Schmutzler RK, Matulonis U, Wickens M, Tutt A. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. Lancet. 2010 Jul 24;376(9737):245-51. Epub 2010 Jul 6. link to original article contains verified protocol PubMed
- Gelmon KA, Tischkowitz M, Mackay H, Swenerton K, Robidoux A, Tonkin K, Hirte H, Huntsman D, Clemons M, Gilks B, Yerushalmi R, Macpherson E, Carmichael J, Oza A. Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a phase 2, multicentre, open-label, non-randomised study. Lancet Oncol. 2011 Sep;12(9):852-61. Epub 2011 Aug 19. link to original article contains verified protocol PubMed
- Ledermann J1, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012 Apr 12;366(15):1382-92. link to original article contains verified protocol PubMed 2013 ASCO Annual Meeting presentation (abstract)
- Kathleen N. Moore, Paul DiSilvestro, Elizabeth S. Lowe, Sally Garnett, Eric Pujade-Lauraine. SOLO1 and SOLO2: Randomized phase III trials of olaparib in patients (pts) with ovarian cancer and a BRCA1/2 mutation (BRCAm). 2014 ASCO Annual Meeting abstract TPS5616. link to abstract
Paclitaxel (Taxol)
| back to top |
Regimen
| Study | Evidence | Comparator |
| Gynecologic Oncology Group et al. 2006 | Phase II | |
| Pujade-Lauraine et al. 2014 (AURELIA) | Phase III | Paclitaxel & Bevacizumab |
Chemotherapy
- Paclitaxel (Taxol) 80 mg/m2 IV over 1 hour once per day on days 1, 8, 15, 22
- Body surface area capped at 2 m2
Supportive medications
- Dexamethasone (Decadron) 10 mg PO/IV once 30 to 60 minutes prior to Paclitaxel (Taxol)
- Diphenhydramine (Benadryl) 25 to 50 mg IV once 30 to 60 minutes prior to Paclitaxel (Taxol)
- H2 blocker 30 to 60 minutes prior to Paclitaxel (Taxol)
28-day cycles
References
- Gynecologic Oncology Group, Markman M, Blessing J, Rubin SC, Connor J, Hanjani P, Waggoner S. Phase II trial of weekly paclitaxel (80 mg/m2) in platinum and paclitaxel-resistant ovarian and primary peritoneal cancers: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Jun;101(3):436-40. Epub 2005 Dec 2. link to original article contains verified protocol PubMed
- Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. link to original article contains verified protocol PubMed
- Update: Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. link to original article PubMed
Paclitaxel & Bevacizumab
| back to top |
Regimen
| Study | Evidence | Comparator |
| Pujade-Lauraine et al. 2014 (AURELIA) | Phase III | Paclitaxel |
Chemotherapy
- Paclitaxel (Taxol) 80 mg/m2 IV once per day on days 1, 8, 15, 22
- Bevacizumab (Avastin) 10 mg/kg IV once per day on days 1 & 15
28-day cycles, given until progression of disease or unacceptable toxicity
References
- Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. link to original article contains verified protocol PubMed
- Update: Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. link to original article PubMed
Paclitaxel, nanoparticle albumin-bound (Abraxane)
| back to top |
Regimen
| Study | Evidence |
| Teneriello et al. 2009 | Phase II |
Chemotherapy
- Paclitaxel, nanoparticle albumin-bound (Abraxane) 260 mg/m2 IV over 30 minutes once on day 1
21-day cycle for 6 to 8 cycles
References
- Teneriello MG, Tseng PC, Crozier M, Encarnacion C, Hancock K, Messing MJ, Boehm KA, Williams A, Asmar L. Phase II evaluation of nanoparticle albumin-bound paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal, or fallopian tube cancer. J Clin Oncol. 2009 Mar 20;27(9):1426-31. Epub 2009 Feb 17. link to original article contains verified protocol PubMed
Pazopanib (Votrient)
| back to top |
Regimen
| Study | Evidence |
| Friedlander et al. 2010 | Phase II |
Chemotherapy
- Pazopanib (Votrient) 800 mg PO once per day
given until progression of disease or unacceptable toxicity
References
- Friedlander M, Hancock KC, Rischin D, Messing MJ, Stringer CA, Matthys GM, Ma B, Hodge JP, Lager JJ. A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. Gynecol Oncol. 2010 Oct;119(1):32-7. Epub 2010 Jun 27. link to original article contains verified protocol PubMed
Pemetrexed (Alimta)
| back to top |
Regimen
| Study | Evidence |
| Miller et al. 2009 | Phase II |
Chemotherapy
- Pemetrexed (Alimta) 900 mg/m2 IV over 10 minutes once on day 1
- Dosage for patients with previous radiation therapy was Pemetrexed (Alimta) 700 mg/m2 IV over 10 minutes once on day 1
Supportive medications
- Folic acid 350 to 600 mcg PO once per day, starting 7 days before pemetrexed, to continue throughout therapy
- Cyanocobalamin (Vitamin B12) 1000 mcg IM once 7 days before pemetrexed (then 1000 mcg to be given once every 9 weeks thereafter)
- Dexamethasone (Decadron) 4 mg PO BID the day before, the day of, and day after Pemetrexed (Alimta)
- No NSAIDs (nonsteroidal anti-inflammatory drugs) for 2 days before or after pemetrexed
21-day cycles
References
- Miller DS, Blessing JA, Krasner CN, Mannel RS, Hanjani P, Pearl ML, Waggoner SE, Boardman CH. Phase II evaluation of pemetrexed in the treatment of recurrent or persistent platinum-resistant ovarian or primary peritoneal carcinoma: a study of the Gynecologic Oncology Group. J Clin Oncol. 2009 Jun 1;27(16):2686-91. Epub 2009 Mar 30. link to original article contains verified protocol PubMed
Topotecan (Hycamtin)
| back to top |
Regimen #1
| Study | Evidence | Comparator |
| Gordon et al. 2001 | Phase III | Pegylated liposomal doxorubicin |
Chemotherapy
- Topotecan (Hycamtin) 1.5 mg/m2 IV over 30 minutes once per day on days 1 to 5
21-day cycles
Regimen #2, 5-day dosing
| Study | Evidence | Comparator |
| Sehouli et al. 2011 | Randomized Phase II | Weekly topotecan |
| Pujade-Lauraine et al. 2014 (AURELIA) | Phase III | Bevacizumab & Topotecan |
Chemotherapy
- Topotecan (Hycamtin) 1.25 mg/m2 IV over 30 minutes once per day on days 1 to 5
21-day cycle for up to 12 months; in AURELIA, topotecan was given until progression of disease or unacceptable toxicity
Regimen #3, weekly dosing
| Study | Evidence | Comparator |
| Sehouli et al. 2011 | Randomized Phase II | 5-day topotecan |
| Pujade-Lauraine et al. 2014 (AURELIA) | Phase III | Bevacizumab & Topotecan |
Chemotherapy
- Topotecan (Hycamtin) 4 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
28-day cycle for up to 12 months; in AURELIA, topotecan was given until progression of disease or unacceptable toxicity
References
- Gordon AN, Fleagle JT, Guthrie D, Parkin DE, Gore ME, Lacave AJ. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol. 2001 Jul 15;19(14):3312-22. link to original article PubMed
- Update: Gordon AN, Tonda M, Sun S, Rackoff W; Doxil Study 30-49 Investigators. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol. 2004 Oct;95(1):1-8. link to original article contains verified protocol PubMed
- Sehouli J, Stengel D, Harter P, Kurzeder C, Belau A, Bogenrieder T, Markmann S, Mahner S, Mueller L, Lorenz R, Nugent A, Wilke J, Kuznik A, Doering G, Wischnik A, Sommer H, Meerpohl HG, Schroeder W, Lichtenegger W, Oskay-Oezcelik G. Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer: a randomized multicenter phase II trial of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group. J Clin Oncol. 2011 Jan 10;29(2):242-8. Epub 2010 Nov 29. link to original article contains verified protocol PubMed
- Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. link to original article contains verified protocol PubMed
- Subgroup analysis: Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. link to original article PubMed
Topotecan & Bevacizumab
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Regimen #1
| Study | Evidence | Comparator |
| Pujade-Lauraine et al. 2014 (AURELIA) | Phase III | Topotecan |
Chemotherapy
- Topotecan (Hycamtin) 4 mg/m2 IV once per day on days 1, 8, 15
- Bevacizumab (Avastin) 10 mg/kg IV once per day on days 1 & 15
28-day cycles, given until progression of disease or unacceptable toxicity
Regimen #2
| Study | Evidence | Comparator |
| Pujade-Lauraine et al. 2014 (AURELIA) | Phase III | Topotecan |
Chemotherapy
- Topotecan (Hycamtin) 1.25 mg/m2 IV once per day on days 1 to 5
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycles, given until progression of disease or unacceptable toxicity
References
- Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. link to original article contains verified protocol PubMed
- Subgroup analysis: Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. link to original article PubMed
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Regimen
| Study | Evidence |
| Rothenberg et al. 2004 | Phase II |
Chemotherapy
- Vinorelbine (Navelbine) 30 mg/m2 IV once per day on days 1 & 8
21-day cycles
References
- Rothenberg ML, Liu PY, Wilczynski S, Nahhas WA, Winakur GL, Jiang CS, Moinpour CM, Lyons B, Weiss GR, Essell JH, Smith HO, Markman M, Alberts DS. Phase II trial of vinorelbine for relapsed ovarian cancer: a Southwest Oncology Group study. Gynecol Oncol. 2004 Dec;95(3):506-12. link to original article contains protocol PubMed
Investigational agents
These are drugs under study with at least some promising results for this disease.