Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients
|ClinicalTrials.gov Identifier: NCT01579812|
Recruitment Status : Active, not recruiting
First Posted : April 18, 2012
Last Update Posted : July 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ovarian, Fallopian Tube, and Primary Peritoneal Cancer||Drug: Metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
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
- Improved Recurrence-Free Survival [ Time Frame: 5 years ]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 ]Determine if metformin therapy is associated with an improvement in overall survival at 2 years compared to historical controls.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579812
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Ronald J. Buckanovich, MD, PhD||University of Michigan|