Status:
COMPLETED
Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
The overall goal of this proposal is to investigate the potential benefit of metformin as a novel therapy for the treatment of endometrial cancer. Investigators will evaluate the effect of short-term ...
Eligibility Criteria
Inclusion
- Be between the ages of 18-75 years old
- Have a confirmed diagnosis of type I endometrial cancer (endometrioid) based on pre-operative endometrial biopsy or dilation and curettage (D\&C)
- Be obese (BMI greater than or equal to 30) with or without diabetes
- Have no contraindications to short-term metformin therapy
- Have a serum creatinine greater 1.0 mg/dL
- Have normal serum transaminase values (AST and ALT)
- Need to be able to undergo metformin treatment for a minimum of 1 weeks but no more than a maximum of 4 weeks prior to surgical staging
Exclusion
- Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin
- Have a history of liver or renal dysfunction
- Have a history of alcoholism
- Have a history of vitamin B12 deficiency
- Are pregnant
- Are currently taking insulin
- Are currently taking any hormonal therapy or have been on hormonal therapy in the past 4 weeks
- Are taking a drug that may significantly interact or influence the metabolism of metformin
- In the opinion of the investigator, the patient is felt not to be appropriate for the study
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01911247
Start Date
May 1 2011
End Date
February 1 2013
Last Update
July 30 2013
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599