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(17):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

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