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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
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.
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
Age
18 - 90 years
Sex
FEMALE
Healthy Volunteers
No
The Ohio State University Medical Center
Columbus, Ohio, United States
Start Date
September 1, 2010
Primary Completion Date
May 1, 2012
Completion Date
May 1, 2015
Last Updated
February 8, 2018
9
ACTUAL participants
carboplatin
DRUG
Bevacizumab
DRUG
Paclitaxel
DRUG
Lead Sponsor
Ritu Salani
Collaborators
NCT05039801
NCT04550494
Data Source & Attribution
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