Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||September 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|