Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT00267696|
Recruitment Status : Completed
First Posted : December 21, 2005
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer||Drug: Bevacizumab Drug: Gemcitabine Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.|
|Study Start Date :||November 2005|
|Primary Completion Date :||September 2013|
|Study Completion Date :||December 2013|
U.S. FDA Resources
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
- 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 ]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 ]The period of time from study entry until disease progression or date of last contact.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|