Difference between revisions of "Ovarian cancer"

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|[http://jco.ascopubs.org/content/32/30/3374.long Du Bois et al. 2014 (AGO-OVAR16)]
 
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# '''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. [http://meetinglibrary.asco.org/content/115898-132 link to abstract]
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<!-- # '''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. [http://meetinglibrary.asco.org/content/115898-132 link to abstract] -->
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# du Bois A, Floquet A, Kim JW, Rau J, del Campo JM, Friedlander M, Pignata S, Fujiwara K, Vergote I, Colombo N, Mirza MR, Monk BJ, Kimmig R, Ray-Coquard I, Zang R, Diaz-Padilla I, Baumann KH, Mouret-Reynier MA, Kim JH, Kurzeder C, Lesoin A, Vasey P, Marth C, Canzler U, Scambia G, Shimada M, Calvert P, Pujade-Lauraine E, Kim BG, Herzog TJ, Mitrica I, Schade-Brittinger C, Wang Q, Crescenzo R, Harter P. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol. 2014 Oct 20;32(30):3374-82. Epub 2014 Sep 15. [http://jco.ascopubs.org/content/32/30/3374.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/25225436 PubMed]
  
 
=Intraperitoneal therapy=
 
=Intraperitoneal therapy=

Revision as of 14:25, 18 September 2016

Use of this site is subject to you reading and agreeing with the terms set forth in the disclaimer.

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


Primary chemotherapy for advanced/metastatic disease

Carboplatin & Docetaxel

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Regimen

Study Evidence Comparator
Vasey et al. 2004 Phase III Carboplatin & Paclitaxel

Chemotherapy

Supportive medications

21-day cycle for 6 cycles

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

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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

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

  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 PMC 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. Epub 2011 Aug 15. link to original article contains verified protocol PubMed

Carboplatin & Gemcitabine

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Regimen

Study Evidence Comparator
Gordon et al. 2011 Phase III Carboplatin & Paclitaxel

Chemotherapy

21-day cycle for up to 6 cycles

Patients with complete response could optionally proceed to receive paclitaxel consolidation.

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

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Regimen #1, AUC 7.5/175

Study Evidence Comparator
Ozols et al. 2003 (GOG 158) Phase III Cisplatin & Paclitaxel

Chemotherapy

Supportive medications

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

Supportive medications

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

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

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

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

18-week course

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 PMC 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. Epub 2011 Aug 15. 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. 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

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Regimen #1

Study Evidence Comparator
Burger et al. 2011 (GOG 218) Phase III Carboplatin & Paclitaxel

Chemotherapy

21-day cycle for 6 cycles

Treatment followed by bevacizumab maintenance.

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

Treatment followed by bevacizumab maintenance.

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

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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

Supportive medications

21-day cycle for 6 cycles

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)

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Regimen

Study Evidence
Alberts et al. 2004 Phase II

Chemotherapy

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

Bevacizumab (Avastin)

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Regimen

Study Evidence
Burger et al. 2011 (GOG 218) Non-randomized
Perren et al. 2011 (ICON7) Non-randomized

Treatment preceded by carboplatin, paclitaxel, bevacizumab.

Chemotherapy

21-day cycle for 12 cycles (ICON7) or up to 16 cycles (GOG 218)

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

Paclitaxel (Taxol)

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Regimen #1

Study Evidence Comparator
Markman et al. 2003 (GOG 178) Phase III Paclitaxel for 12 cycles

Chemotherapy

28-day cycle for 3 cycles

Regimen #2

Study Evidence Comparator
Markman et al. 2003 (GOG 178) Phase III Paclitaxel for 3 cycles

Chemotherapy

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

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

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

21-day cycle for 12 cycles

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
    1. 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
  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. 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
  4. 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)

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Regimen

Study Evidence Comparator
Du Bois et al. 2014 (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

24-month course

References

  1. du Bois A, Floquet A, Kim JW, Rau J, del Campo JM, Friedlander M, Pignata S, Fujiwara K, Vergote I, Colombo N, Mirza MR, Monk BJ, Kimmig R, Ray-Coquard I, Zang R, Diaz-Padilla I, Baumann KH, Mouret-Reynier MA, Kim JH, Kurzeder C, Lesoin A, Vasey P, Marth C, Canzler U, Scambia G, Shimada M, Calvert P, Pujade-Lauraine E, Kim BG, Herzog TJ, Mitrica I, Schade-Brittinger C, Wang Q, Crescenzo R, Harter P. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol. 2014 Oct 20;32(30):3374-82. Epub 2014 Sep 15. link to original article contains verified protocol PubMed

Placebo

back to top

Regimen

Study Evidence Comparator
Du Bois et al. 2014 (AGO-OVAR16) Phase III Pazopanib

No treatment after initial platinum-taxane treatment. Used as a comparator arm and here for reference purposes only.

References

  1. du Bois A, Floquet A, Kim JW, Rau J, del Campo JM, Friedlander M, Pignata S, Fujiwara K, Vergote I, Colombo N, Mirza MR, Monk BJ, Kimmig R, Ray-Coquard I, Zang R, Diaz-Padilla I, Baumann KH, Mouret-Reynier MA, Kim JH, Kurzeder C, Lesoin A, Vasey P, Marth C, Canzler U, Scambia G, Shimada M, Calvert P, Pujade-Lauraine E, Kim BG, Herzog TJ, Mitrica I, Schade-Brittinger C, Wang Q, Crescenzo R, Harter P. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol. 2014 Oct 20;32(30):3374-82. Epub 2014 Sep 15. link to original article contains verified protocol PubMed

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

  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)

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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

21-day cycle for 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

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Regimen #1

Study Evidence
Strauss et al. 2007 Phase II

Chemotherapy

Supportive medications

21-day cycle for 6 cycles

Regimen #2

Study Evidence
Kushner et al. 2007 Phase II

Chemotherapy

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

  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

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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

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

  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
    1. 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

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Regimen

Study Evidence Comparator
Pfisterer et al. 2006 Phase III Carboplatin
Aghajanian et al. 2012 (OCEANS) Phase III Carboplatin, Gemcitabine, Bevacizumab

Chemotherapy

21-day cycle for 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. Epub 2012 Apr 23. link to original article contains verified protocol PubMed
    1. 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

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Regimen

Study Evidence Comparator
Aghajanian et al. 2012 (OCEANS) Phase III Carboplatin & Gemcitabine

Initial therapy

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

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. Epub 2012 Apr 23. link to original article contains verified protocol PubMed
    1. 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

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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

Supportive medications

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
  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
    1. 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
  3. 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

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Regimen

Study Evidence
Rose et al. 2003 Phase II

Chemotherapy

Supportive medications

21-day cycles

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

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Regimen

Study Evidence Comparator
Parmar et al. 2003 (ICON4/AGO-OVAR-2.2) Phase III Carboplatin
Carboplatin & Paclitaxel

Chemotherapy

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)

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Regimen

Study Evidence
Rose et al. 2003 Phase II

Chemotherapy

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

  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)

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Regimen #1

Study Evidence Comparator
Gordon et al. 2001 Phase III Topotecan
Mutch et al. 2007 Phase III Gemcitabine

Chemotherapy

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

Supportive medications

28-day cycles

References

  1. 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
    1. 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
  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
    1. 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

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Regimen

Study Evidence Comparator
Pujade-Lauraine et al. 2014 (AURELIA) Phase III Pegylated liposomal doxorubicin

Chemotherapy

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
    1. 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

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Regimen

Study Evidence
Ferrandina et al. 2005 Phase II

Chemotherapy

Supportive medications

21-day cycles

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)

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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

  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)

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Regimen #1

Study Evidence Comparator
Mutch et al. 2007 Phase III Pegylated liposomal doxorubicin

Chemotherapy

21-day cycles

Regimen #2

Study Evidence Comparator
Ferrandina et al. 2008 Phase III Pegylated liposomal doxorubicin

Chemotherapy

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)

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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

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

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)

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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

28-day cycles

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
    1. 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

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Regimen

Study Evidence Comparator
Pujade-Lauraine et al. 2014 (AURELIA) Phase III Paclitaxel

Chemotherapy

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
    1. 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)

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Regimen

Study Evidence
Teneriello et al. 2009 Phase II

Chemotherapy

21-day cycle for 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)

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Regimen

Study Evidence
Friedlander et al. 2010 Phase II

Chemotherapy

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. Epub 2010 Jun 27. link to original article contains verified protocol PubMed

Pemetrexed (Alimta)

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Regimen

Study Evidence
Miller et al. 2009 Phase II

Chemotherapy

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

  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)

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Regimen #1

Study Evidence Comparator
Gordon et al. 2001 Phase III Pegylated liposomal doxorubicin

Chemotherapy

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

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

28-day cycle for up to 12 months; in AURELIA, topotecan was given until progression of disease or unacceptable toxicity

References

  1. 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
    1. 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
  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
    1. 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

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

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
    1. 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

Vinorelbine (Navelbine)

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Regimen

Study Evidence
Rothenberg et al. 2004 Phase II

Chemotherapy

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

Investigational agents

These are drugs under study with at least some promising results for this disease.

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