A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.
In this study participants will receive the drug combination gemcitabine/carboplatin and
bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing
and the participant is not experiencing any unacceptable side effects, participation can
continue up to 2 years. The study is being done to find the effectiveness, safety and
tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of
new blood vessels in the body. It is part of this study to see if stopping the growth of new
blood vessels in the body will help stop the growth and the spread of cancer. The other two
chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the
treatment of ovarian cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the antitumor activity of gemcitabine/carboplatin/bevacizumab regimen as measured by the probability of surviving progression-free for at least 6 months or responding.
To progression of disease
Larry J. Copeland, MD
Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology
United States: Food and Drug Administration
|The Ohio State University & James Cancer Hospital||Columbus, Ohio 43210|