Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer
The Study Drug:
Metformin is designed to treat both diabetes and insulin resistance. Both diabetes and
insulin resistance have been linked to endometrial cancer. Although you do not have a
diagnosis of diabetes, metformin may still have an affect on your cancer cells.
Study Visit (before taking Metformin):
If you are found eligible to take part in this study, you will have a study visit before you
begin taking Metformin. The following tests and procedures will be performed:
- Blood (about 2 tablespoons) and urine will be collected for research to look at
different hormone levels.
- If needed, a fasting glucose level will be obtained.
- If you are found not to be eligible your blood, urine, and tissue for research will be
discarded.
Study Drug Administration:
You will take metformin, by mouth, 1 time each morning, with breakfast, for at least 7 days
and up to 30 days until your scheduled surgery is performed. You will record the dates and
times you take metformin on a study drug calendar provided by the study staff. You will not
take metformin on the day of your surgery.
Study Tests (on the day of your surgery):
You will bring your study drug calendar to the clinic on the day of your surgery. The
following tests and procedures will also be performed:
- Blood (about 2 tablespoons) and urine will be collected for routine tests and to check
different hormone levels.
- During surgery, you will have a second endometrial biopsy for biomarker testing.
Length of Study:
You will be off study after your surgical procedure.
This is an investigational study.
Up to 30 women will take part in this study. Up to 25 participants will take part at MD
Anderson.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Increase in s6K Expression
30 days
No
Pamela Soliman, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0927
NCT01205672
September 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |