Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Phase I study proposed to evaluate:
- Tolerability of IV regimen carboplatin, paclitaxel and bevacizumab in the neoadjuvant
setting prior to surgery.
- Safety/Toxicity of IV regimen in this patient population
- Treatment is Carboplatin area under the concentration curve (AUC) 5, Bevacizumab
15mg/m2, and starting dose of paclitaxel of 60mg/m2 and will be escalated in intervals
of 10mg/m2 to a maximum dose of 80mg/m2.
- Patients will receive cycles 1-3 of carboplatin, bevacizumab, and paclitaxel and then
cycle 4 will be carboplatin and paclitaxel followed by surgical intervention within 6
weeks of cycle 4.
- Post surgical treatment per physician discretion
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.
3 patients per dose level with minmum of 4 weeks observation period
Ritu Salani, MD
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|