GOG-0218 — A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Advanced Ovarian Cancer

Phase 3 · 2011 · Ovarian Cancer

Design

Three-arm, double-blind trial: chemotherapy plus placebo; chemotherapy plus concurrent bevacizumab; or chemotherapy plus concurrent and maintenance bevacizumab.

Population

Newly diagnosed stage III (incompletely resected) or stage IV epithelial ovarian, primary peritoneal, or fallopian tube cancer after debulking.

Primary Endpoint

progression-free survival (PFS)

Key Result

Median PFS 14.1 months with concurrent/maintenance bevacizumab vs 10.3 months with chemotherapy alone (HR 0.72); no overall survival benefit.

Guideline Impact

Supported FDA approval and NCCN inclusion of bevacizumab in front-line ovarian cancer