Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.
Fallopian Tube Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.|
- 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. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.
- Overall Survival for Patients Treated With the Regimen. [ Time Frame: To progression of Disease ] [ Designated as safety issue: No ]The period of time from study entry until disease progression or date of last contact.
|Study Start Date:||November 2005|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Other Name: Avastin®Drug: Gemcitabine
A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycleDrug: Carboplatin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267696
|United States, Ohio|
|The Ohio State University & James Cancer Hospital|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Larry J. Copeland, MD||Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology|