Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Summary

This randomized phase III trial studies bevacizumab and intravenous (given into a vein) chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (given into the abdominal cavity) chemotherapy in treating patients with stage II-III ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bevacizumab together with intravenous chemotherapy is more effective than giving bevacizumab together with intraperitoneal chemotherapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Timeline

Start

2009-08-11

Primary completion

2016-01-11

Completion

2016-01-11

Outcome

Missed primary endpoint

registry analysis (unspecified test); Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) vs Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP); p = 0.341; Hazard Ratio (HR) 0.94 (95% CI 0.81 to 1.09); Log Rank; note: P value not adjusted for multiplicity. Significance Threshold = 0.027 NCT00951496 ↗

registry analysis (unspecified test); Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) vs Arm III (Paclitaxel IP, Cisplatin, Bevacizumab); p = 0.587; Hazard Ratio (HR) 0.99 (95% CI 0.86 to 1.15); Log Rank; note: P value not adjusted for multiplicity. Significance threshold = 0.027 accounting for 2 correlated primary hypotheses. NCT00951496 ↗

Publications

• Walker JL, Brady MF, Wenzel L, Fleming GF, Huang HQ, DiSilvestro PA, Fujiwara K, Alberts DS, Zheng W, Tewari KS, Cohn DE, Powell MA, Van Le L, Davidson SA, Gray HJ, Rose PG, Aghajanian C, Myers T, Alvarez Secord A, Rubin SC, Mannel RS. Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol. 2019 Jun 1;37(16):1380-1390. doi: 10.1200/JCO.18.01568. Epub 2019 Apr 19.

Drugs

Indications