drugset / Trial / NCT01167712

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

NCT01167712 ↗

Phase 3 Active not recruiting 692 enrolled National Cancer Institute (NCI) NRG Oncology · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that tumors need to grow. It is not yet known whether giving paclitaxel with combination chemotherapy once every three weeks is more effective than giving paclitaxel once a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.

Timeline

Start
2010-09-27
Primary completion
2015-12-01
Completion
2026-07-02

Outcome

Missed primary endpoint

paper Overall, weekly paclitaxel, as compared with paclitaxel administered every 3 weeks, did not prolong progression-free survival among patients with ovarian cancer. PMID 26933849 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Carboplatin Small molecule — Intravenous