Difference between revisions of "Ovarian cancer"

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===References===
 
===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. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1553473/ link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16882344 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. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1553473/ link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16882344 PubMed]
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# '''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. doi: 10.1200/JCO.2010.33.8566. Epub 2011 Aug 15. [http://jco.ascopubs.org/content/29/27/3628.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21844495 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. doi: 10.1200/JCO.2010.33.8566. Epub 2011 Aug 15. [http://jco.ascopubs.org/content/29/27/3628.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21844495 PubMed]
  
 
==Carboplatin & Gemcitabine==
 
==Carboplatin & Gemcitabine==

Revision as of 14:24, 10 January 2015

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Primary chemotherapy for advanced/metastatic disease

Carboplatin & Docetaxel

Regimen, Vasey et al. 2004

Level of Evidence: Phase III

21-day cycles x 6 cycles

Supportive medications:

References

  1. 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

Regimen, Pignata et al. 2006 (MITO-2)

Level of Evidence: Phase III

Eligibility criteria for Pignata et al. 2006 & Pignata et al. 2011 included: "a cytologic or histologic diagnosis of epithelial ovarian cancer (stage IC to IV according to International Federation of Gynecology and Obstetrics staging system).

21-day cycles x 3 to 6 cycles; all patients received 3 cycles of therapy. Patients with stable or responsive disease received an additional 3 cycles.

Supportive medications (per Pignata et al. 2006):

  • "No prophylactic use of G-CSF was recommended. Therapeutic and prophylactic use of G-CSF was allowed for febrile or afebrile grade 4 neutropenia."

References

  1. 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 original article contains verified protocol PubMed
    1. 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. doi: 10.1200/JCO.2010.33.8566. Epub 2011 Aug 15. link to original article contains verified protocol PubMed

Carboplatin & Gemcitabine

Regimen, Gordon et al. 2011

Level of Evidence: Phase III

21-day cycles x up to 6 cycles; patients with complete response could optionally proceed to receive consolidation

Consolidation

28-day cycles x up to 12 cycles

References

  1. 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

Regimen #1, Ozols et al. 2003

Level of Evidence: Phase III

21-day cycles x 6 cycles

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
  • Diphenhydramine (Benadryl) 50 mg IV once 30 minutes prior to paclitaxel
  • Cimetidine (Tagamet) 300 mg IV once 30 minutes prior to paclitaxel

Regimen #2, Vasey et al. 2004 & Pignata et al. 2006 (MITO-2)

Level of Evidence: Phase III

21-day cycles x 6 cycles; in Pignata et al. 2011 (MITO-2), all patients received 3 cycles of therapy. Patients with stable or responsive disease received an additional 3 cycles.

Supportive medications (per Vasey et al. 2004):

  • Dexamethasone (Decadron) 20 mg PO given twice, at 12 and 6 hours prior to paclitaxel
  • Diphenhydramine (Benadryl) 50 mg IV or chlorpheniramine 10 mg IV once 30 minutes prior to paclitaxel
  • Ranitidine (Zantac) 50 mg IV or Cimetidine (Tagamet) 300 mg IV once 30 minutes prior to paclitaxel
  • Ondansetron (Zofran) 8 mg or Granisetron (Kytril) 3 mg for antiemesis

Regimen #3, Katsumata et al. 2009

Level of Evidence: Phase III

21-day cycles x 6 to 9 cycles, depending on response

Supportive medications:

  • "Standard premedication"

Regimen #4, Katsumata et al. 2009 (dose-dense paclitaxel)

Level of Evidence: Phase III

21-day cycles x 6 to 9 cycles, depending on response

Supportive medications:

  • "Standard premedication"

Regimen #5, Gordon et al. 2011

Level of Evidence: Phase III

21-day cycles x up to 6 cycles; patients with complete response could optionally proceed to receive consolidation

Consolidation

28-day cycles x up to 12 cycles

Regimen #6, Burger et al. 2011 (GOG-0218) & Perren et al. 2011 (ICON7)

Level of Evidence: Phase III

21-day cycles x 6 cycles

Regimen #7, Pignata et al. 2013 (MITO-7, weekly carboplatin & paclitaxel)

Level of Evidence: Phase III

18 administrations given

References

  1. 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
  2. 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
  3. 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 original article contains verified protocol PubMed
  4. 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
  5. 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
  6. 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
  7. 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
  8. Sandro Pignata, Giovanni Scambia, Rossella Lauria, Francesco Raspagliesi, Pierluigi Benedetti Panici, Gennaro Cormio, Dionyssios Katsaros, Roberto Sorio, Giovanna Cavazzini, Gabriella Ferrandina, Enrico Breda, Viviana Murgia, Cosimo Sacco, Nuria Maria Asensio Sierra, Carmela Pisano, Vanda Salutari, Beatrice E. Weber, Eric Pujade-Lauraine, Ciro Gallo, Francesco Perrone. A randomized multicenter phase III study comparing weekly versus every 3 weeks carboplatin (C) plus paclitaxel (P) in patients with advanced ovarian cancer (AOC): Multicenter Italian Trials in Ovarian Cancer (MITO-7)—European Network of Gynaecological Oncological Trial Groups (ENGOT-ov-10) and Gynecologic Cancer Intergroup (GCIG) trial. 2013 ASCO Annual Meeting abstract LBA5501. link to abstract

Carboplatin, Paclitaxel, Bevacizumab

Regimen #1, Burger et al. 2011 (GOG-0218)

Level of Evidence: Phase III

21-day cycle x 1 cycle, then

21-day cycles x 5 cycles, then

21-day cycles x up to 16 cycles

Regimen #2, Perren et al. 2011 (ICON7)

Level of Evidence: Phase III

  • 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 is not given in cycle 1 if chemotherapy starts within 4 weeks of surgery. If >4 weeks after surgery: Bevacizumab (Avastin) 7.5 mg/kg IV once on day 1

21-day cycle x 1 cycle, then

21-day cycles x 5 cycles, then

21-day cycles x 12 cycles

References

  1. 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
  2. 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

Regimen, Ozols et al. 2003; Armstrong et al. 2006; Walker et al. 2006

Level of Evidence: Phase III

21-day cycles x 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

  1. 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
  2. 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
  3. 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)

Regimen, Alberts et al. 2004

Level of Evidence: Phase II

28-day cycles

References

  1. 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)

Regimen #1, Markman et al. 2003 (GOG 178)

Level of Evidence: Phase III

28-day cycles x 3 or 12 cycles

Regimen #2, Micha et al. 2005 & Abaid et al. 2010

21-day cycles x 12 cycles

Supportive medications:

References

  1. 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
  2. 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
  3. 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
  4. 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

Pazopanib (Votrient)

Regimen, Du Bois et al. 2013 (AGO-OVAR16)

Level of Evidence: Phase III

Patients enrolled in Du Bois et al. 2013 (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.

24-month course

References

  1. 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

Regimen, Du Bois et al. 2013 (AGO-OVAR16)

Level of Evidence: Phase III

No treatment. Used as a comparator arm and here for reference purposes only.

References

  1. 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

Regimen #1, Armstrong et al. 2006

Level of Evidence: Phase III

  • 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

21-day cycles x 6 cycles

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

Regimen #2, Walker et al. 2006

Level of Evidence: Phase III

  • 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

21-day cycles x 6 cycles

Supportive medications:

  • Additional 1 liter normal saline to be infused immediately after intraperitoneal paclitaxel
  • Supportive medications left to investigator discretion

References

  1. 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
  2. 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)

Regimen

Level of Evidence: Phase III

21-day cycles x 6 to 10 cycles

References

  1. 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
  2. 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

Regimen #1, Strauss et al. 2007

Level of Evidence: Phase II

21-day cycles x 6 cycles

Supportive medications:

Regimen #2, Kushner et al. 2007

Level of Evidence: Phase II

28-day cycles x 6 cycles

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

References

  1. 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
  2. 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

Regimen, Pujade-Lauraine et al. 2010 (CALYPSO)

Level of Evidence: Phase III

CALYPSO: Caelyx in Platinum Sensitive Ovarian patients

28-day cycles x 6 or more cycles, depending on response and toxicity

Supportive medications:

  • "Antiemetics, including a serotonin antagonist and corticosteroid with 5-HT3 antagonist"

References

  1. 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
  2. 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. doi: 10.1038/bjc.2012.307. Epub 2012 Jul 26. link to original article contains verified protocol PubMed

Carboplatin & Gemcitabine

Regimen, Pfisterer et al. 2006 & Aghajanian et al. 2012 (OCEANS)

Level of Evidence: Phase III

21-day cycles x 6 to 10 cycles

References

  1. 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
  2. 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. doi: 10.1200/JCO.2012.42.0505. Epub 2012 Apr 23. link to original article contains verified protocol PubMed

Carboplatin, Gemcitabine, Bevacizumab

Regimen, Aghajanian et al. 2012 (OCEANS)

Level of Evidence: Phase III

Initial therapy

21-day cycles x 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

21-day cycles, given until progression of disease or unacceptable toxicity

References

  1. 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. doi: 10.1200/JCO.2012.42.0505. Epub 2012 Apr 23. link to original article contains verified protocol PubMed

Carboplatin & Paclitaxel

Regimen, Parmar et al. 2003 (ICON4/AGO-OVAR-2.2), Pujade-Lauraine et al. 2010 (CALYPSO)

Level of Evidence: Phase III

CALYPSO: Caelyx in Platinum Sensitive Ovarian patients

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

  1. 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
  2. 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
  3. 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. doi: 10.1038/bjc.2012.307. Epub 2012 Jul 26. link to original article contains verified protocol PubMed

Cisplatin & Gemcitabine

Regimen, Rose et al. 2003

Level of Evidence: Phase II

21-day cycles

Supportive medications:

References

  1. 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

Regimen, Parmar et al. 2003 (ICON4/AGO-OVAR-2.2)

Level of Evidence: Phase III

21-day cycles

References

  1. 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)

Regimen, Rose et al. 2003

Level of Evidence: Phase II

21-day cycles

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

References

  1. 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)

Regimen #1, Gordon et al. 2004 & Mutch et al. 2007

Level of Evidence: Phase III

28-day cycles

Regimen #2, Ferrandina et al. 2008; Pujade-Lauraine et al. 2014 (AURELIA); Stockler et al. 2014 (AURELIA)

Level of Evidence: Phase III

28-day cycles

Supportive medications:

References

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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

Regimen, Pujade-Lauraine et al. 2014 (AURELIA) & Stockler et al. 2014 (AURELIA)

Level of Evidence: Phase III

28-day cycles, given until progression of disease or unacceptable toxicity

References

  1. 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
  2. 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

Regimen, Ferrandina et al. 2005

Level of Evidence: Phase II

21-day cycles

Supportive medications:

  • Metoclopramide (Reglan) before chemotherapy

References

  1. 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)

Regimen, Rose et al. 1998

Level of Evidence: Phase II

  • 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

  1. 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)

Regimen #1, Mutch et al. 2007

Level of Evidence: Phase III

21-day cycles

Regimen #2, Ferrandina et al. 2008

Level of Evidence: Phase III

28-day cycles

References

  1. 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
  2. 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)

Regimen #1, Audeh et al. 2010; Gelmon et al. 2011; Ledermann et al. 2012

Level of Evidence: Phase II

Regimen #2, Moore et al. 2014 (SOLO1 & SOLO2)

Level of Evidence: Phase III

Moore et al. 2014 (SOLO1 & SOLO2) is an ongoing clinical trial. This is not the FDA-approved dose.

References

  1. 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
  2. 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
  3. 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)
  4. 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)

Regimen, Gynecologic Oncology Group et al. 2006; Pujade-Lauraine et al. 2014 (AURELIA); Stockler et al. 2014 (AURELIA)

Level of Evidence: Phase II

  • 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

28-day cycles

Supportive medications:

  • Dexamethasone (Decadron) 10 mg PO/IV once 30 to 60 minutes prior to paclitaxel
  • Diphenhydramine (Benadryl) 25 to 50 mg IV once 30 to 60 minutes prior to paclitaxel
  • H2 blocker 30 to 60 minutes prior to paclitaxel

References

  1. 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
  2. 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
  3. 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

Regimen, Pujade-Lauraine et al. 2014 (AURELIA) & Stockler et al. 2014 (AURELIA)

Level of Evidence: Phase III

28-day cycles, given until progression of disease or unacceptable toxicity

References

  1. 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
  2. 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)

Regimen, Teneriello et al. 2009

Level of Evidence: Phase II

21-day cycles x 6 to 8 cycles

References

  1. 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)

Regimen, Friedlander et al. 2010

Level of Evidence: Phase II

given until progression of disease or unacceptable toxicity

References

  1. 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. doi: 10.1016/j.ygyno.2010.05.033. Epub 2010 Jun 27. link to original article contains verified protocol PubMed

Pemetrexed (Alimta)

Regimen, Miller et al. 2009

Level of Evidence: Phase II

21-day cycles

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

References

  1. 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)

Regimen #1, Gordon et al. 2004

Level of Evidence: Phase III

21-day cycles

Regimen #2, Sehouli et al. 2011; Pujade-Lauraine et al. 2014 (AURELIA); Stockler et al. 2014 (AURELIA)

Level of Evidence: Randomized Phase II, >20 per arm

21-day cycles x up to 12 months; in Pujade-Lauraine et al. 2014 (AURELIA) & Stockler et al. 2014 (AURELIA), topotecan was given until progression of disease or unacceptable toxicity

Regimen #3, Sehouli et al. 2011 (weekly topotecan); Pujade-Lauraine et al. 2014 (AURELIA); Stockler et al. 2014 (AURELIA)

Level of Evidence: Randomized Phase II, >20 per arm

28-day cycles x up to 12 months; in Pujade-Lauraine et al. 2014 (AURELIA) & Stockler et al. 2014 (AURELIA), topotecan was given until progression of disease or unacceptable toxicity

References

  1. 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
  2. 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
  3. 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
  4. 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

Regimen #1, Pujade-Lauraine et al. 2014 (AURELIA) & Stockler et al. 2014 (AURELIA)

Level of Evidence: Phase III

28-day cycles, given until progression of disease or unacceptable toxicity

Regimen #2, Pujade-Lauraine et al. 2014 (AURELIA) & Stockler et al. 2014 (AURELIA)

Level of Evidence: Phase III

21-day cycles, given until progression of disease or unacceptable toxicity

References

  1. 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
  2. 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

Vinorelbine (Navelbine)

Regimen, Rothenberg et al. 2004

Level of Evidence: Phase II

21-day cycles

References

  1. 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
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