Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients
Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Metformin, Targeting Cancer Stem Cells for the Prevention of Relapse in Patients With Stage IIC/III/IV Ovarian, Fallopian Tube, and Primary Peritoneal Cancer|
- Improved Recurrence-Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Determine if metformin administered in combination with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube cancer will improve recurrence-free survival (RFS) at 18 months compared to historical controls.
- Overall Survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]Determine if metformin therapy is associated with an improvement in overall survival at 2 years compared to historical controls.
|Study Start Date:||October 2011|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.
Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.
Other Name: Fortamet, Glucophage, Glumetza, Riomet
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579812
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Ronald J. Buckanovich, MD, PhD||University of Michigan|