A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Summary

This multicenter, double-blind, 2-arm, randomized study will evaluate the efficacy and safety of bevacizumab plus paclitaxel and caboplatin compared with placebo plus paclitaxel and caboplatin in Chinese participants with newly diagnosed, previously untreated Stage III or Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants whose disease has not progressed after six cycles of paclitaxel and carboplatin with either bevacizumab or placebo will continue treatment with either bevacizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 22 cycles, whichever occurs first.

Timeline

Start

2018-08-15

Primary completion

2021-05-26

Completion

2023-05-11

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo + Paclitaxel + Carboplatin vs Bevacizumab + Paclitaxel + Carboplatin; p <.0001; Hazard Ratio (HR) 0.30 (95% CI 0.17 to 0.53) NCT03635489 ↗

paper Median PFS was 22.6 months with bevacizumab + CP (95% confidence interval [CI]=18.6, not estimable) and 12.3 months (95% CI=9.5, 15.0) with placebo + CP PMID 38872480 ↗

Publications

• Wu X, Liu J, An R, Yin R, Zhang Y, Zhou H, He A, Wang L, Zhang J, Liu Z, Duan W, Zhu J, Lou G, Chen G, Cheng Y, Xue F, Nick S, Wang H, Li D. First-line bevacizumab plus chemotherapy in Chinese patients with stage III/IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer: a phase III randomized controlled trial. J Gynecol Oncol. 2024 Sep;35(5):e99. doi: 10.3802/jgo.2024.35.e99. Epub 2024 Apr 22.
• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Paclitaxel	Small molecule	175 mg/m2	Intravenous

Indications