Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more after last platinum-based treatment
Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more after last platinum-based treatment
For more detailed information, please click on the clinical trial ID number.
| Drug Class | Trial ID # | Phase | Drugs | Clinical Trial Title | Key Conclusion and Results |
|---|---|---|---|---|---|
| Standard of Care Chemotherapy | |||||
| Chemotherapy | NCT00002894 | III | Cisplatin, Carboplatin, Paclitaxel | A Randomized Trial of Paclitaxel (Taxol) in Combination With Platinum Chemotherapy vs. Conventional Platinum-Based Chemotherapy in the Treatment of Women With Relapsed Ovarian Cancer (ICON4) | Improved PFS and OS with addition of paclitaxel to platinum CisPt/CarboPt+Pac vs CisPt/CarboPt: ORR: 66 vs 54% v. 6/2017 |
| Chemotherapy | NCT00102414 | III | Carboplatin, Gemcitabine | A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy (NCIC OV15) | Improved PFS with addition of gemcitabine to carboplatin CarboPt+Gem vs. CarboPt: ORR: 47.2 vs 30.9%* v. 6/2017 |
| Chemotherapy | NCT00538603 | III | Carboplatin, Liposomal doxorubicin, Paclitaxel | Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO) | Carboplatin+liposomal doxorubicin has similar PFS and OS to carboplatin+paclitaxel with less sensory neuropathy CarboPt+PLD vs CarboPt+Pac: PFS: 11.3 vs 9.4 months* v. 6/2017 |
| Standard of Care Targeted Drugs | |||||
| DNA Damage Repair Pathway Inhibitors:PARP | NCT01078662 | II | Olaparib | A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation (Study 42) | Olaparib shows promising responses in heavily pretreated gBRCA MUT patients ORR: 46% v. 9/2018 |
| DNA Damage Repair Pathway Inhibitors:PARP | Rucaparib FDA Approval Data | II | Rucaparib | Treatment of BRCA-mutated Ovarian Cancer After 2 or More Chemotherapies | Rucaparib shows promising responses in BRCA MUT patients ORR: 66% v. 9/2018 |
| Angiogenesis Inhibitors: VEGF | NCT00434642 | III | Bevacizumab, Carboplatin, Gemcitabine | A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma (OCEANS) | Improved ORR and PFS with addition of bevacizumab to carboplatin and gemcitabine, but no OS difference CarboPt+Gem+Bev vs CarboPt+Gem+Placebo: ORR: 78.5 vs 57.4%* v. 1/2017 |
| Angiogenesis Inhibitors: VEGF | NCT00565851 | III | Bevacizumab, Carboplatin, Paclitaxel | A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865) (GOG 0213) | Improved ORR, PFS and OS with the addition of bevacizumab to carboplatin + paclitaxel CarboPt+Pac+Bev vs CarboPt+Pac: ORR: 78 vs 59%* v. 7/2018 |
| Angiogenesis Inhibitors: VEGF | NCT01837251 | III | Bevacizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin | A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer | Improved PFS with addition of liposomal doxorubicin to carboplatin+bevacizumab compared to gemcitabine CarboPt+Gem+Bev vs CarboPt+PLD+Bev: PFS: 11.7 vs 13.3 months* v. 11/2018 |
| Drugs in NCCN Guidelines | |||||
| Angiogenesis Inhibitors: VEGF | NCT01305213 | II | Bevacizumab, Fosbretabulin | A Randomized Phase II Evaluation of Single-Agent Bevacizumab (NSC #704865) and Combination Bevacizumab With Fosbretabulin Tromethamine (CA4P) (NSC #752293) in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma | Improved PFS with addition of fosbretabulin to bevacizumab Fos+Bev vs Bev: PFS: 7.6 vs 6.1 months v. 4/2017 |
| Drugs in Clinical Development | |||||
| DNA Damage Repair Pathway Inhibitors:PARP | NCT01116648 | II | Cediranib, Olaparib | Phase I/II Study of Cediranib and Olaparib in Combination for Treatment of Recurrent Papillary-Serous Ovarian, Fallopian Tube, or Peritoneal Cancer or for Treatment of Recurrent Triple-Negative Breast Cancer | Improved ORR and PFS for olaparib+cediranib combination, particularly in patients with gBRCA WT or unknown BRCA status Ola+Ced vs Ola: gBRCA WT or UNK: v. 6/2017 |
| DNA Damage Repair Pathway Inhibitors:PARP | NCT01540565 | II | Veliparib | A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (NSC#737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation | Veliparib shows encouraging activity in gBRCA MUT cancer ORR: 35% v. 1/2017 |
| DNA Damage Repair Pathway Inhibitors:PARP | NCT01891344 | II | Rucaparib | A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2 Part1) | Improved ORR and PFS with rucaparib treatment in BRCA MUT patients BRCA MUT vs BRCA WT LOH high vs BRCA WT LOH low: ORR: 80 vs 29 vs 10%* v. 4/2017 |
| DNA Damage Repair Pathway Inhibitors:PARP | NCT02354586 | II | Niraparib | A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens (QUADRA) | Niraparib shows promising activity in late-line treatment setting BRCA MUT: v. 11/2018 |
| DNA Damage Repair Pathway Inhibitors:PARP | NCT02734004 | I/II | Durvalumab, Olaparib | A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors (MEDIOLA) | Promising activity of olaparib+durvalumab combination in gBRCA MUT ORR: 72% v. 8/2018 |
| Cell Cycle Inhibitors:p53 | NCT02098343 | II | APR-246, Carboplatin, Liposomal doxorubicin | PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 | Encouraging activity of APR-246+carboplatin+liposomal doxorubicin in TP53-mutated platinum-sensitive and partially platinum-sensitive patients ORR: 62% v. 8/2018 |
| Immunotherapy: Checkpoint Inhibitors/CTLA-4 | NCT01611558 | II | Ipilimumab | A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects | Ipilimumab shows encouraging anti-tumor activity, but with serious side effects ORR: 10.3% v. 4/2017 |
| Immunotherapy: Antibodies/FRalpha | NCT00849667 | III | Carboplatin, Farletuzumab, Paclitaxel | A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse | PFS and OS benefit with addition of farletuzumab to carboplatin+paclitaxel in patients with baseline CA125 levels ≤3xULN CarboPt+Pac+Far vs CarboPt+Pac+Placebo: PFS: 13.6 vs 8.8 months* v. 11/2017 |