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)

Trial ID # NCT00434642; OCEANS
Phase III
Drug Class Angiogenesis Inhibitors: VEGF
Drug Name Bevacizumab
Alternate Drug Names immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial Bevacizumab, Carboplatin, Gemcitabine
Eligible Participant

Platinum-sensitive ovarian cancer at first recurrence

Patients Enrolled

484

Therapy Setting

Recurrence

Study Design

Double Blind, Randomized

Endpoints

ORR, PFS, OS, evaluated per RECIST

Efficacy

CarboPt+Gem+Bev vs CarboPt+Gem+Placebo:

ORR: 78.5 vs 57.4% (p<0.001)
PFS: 12.4 vs 8.4 months, HR: 0.48 (0.39-0.61, p<0.001)
OS: 33.6 vs 32.9 months, HR: 0.95 (0.77-1.18, p=0.65)

Clinically Significant Adverse Events

CarboPt+Gem+Bev vs CarboPt+Gem+Placebo:
Serious AE: GI perforation (2 pts after discontinuation of treatment vs 0), fistula/abscess (1.6% vs 1 pt), thromboembolic event (7 vs 3%) CNS bleeding (1% vs 1 pt), non-CNS bleeding (5.7 vs 1%)
Grade 3-4 AE: hypertension (17% vs 1 pt), proteinuria (8.5 vs 1%)

Conclusion

Improved ORR and PFS, no OS difference

Reference

Aghajanian C et al. 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) 30:2039-45
http://www.ncbi.nlm.nih.gov/pubmed/22529265

Aghajanian C et al. 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) 139(1):10-6
http://www.ncbi.nlm.nih.gov/pubmed/26271155