drugset / Trial / NCT01219777

Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian

NCT01219777 ↗

Phase 1 Completed 9 enrolled Ritu Salani Genentech, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.

Timeline

Start
2010-09
Primary completion
2012-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/m2 Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Paclitaxel Small molecule 60 mg/m2 Intravenous
Subject Paclitaxel Small molecule 70 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous