Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial 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: NCT01205672|
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : June 2, 2017
The goal of this research study is to learn if metformin can affect endometrial cancer cells in women who do not have diabetes.
1. To determine the molecular effects of metformin and associated physiologic changes in insulin/glucose metabolism on the mTOR (mammalian target of rapamycin) signaling pathway in the endometrium of women with endometrial cancer
- To describe the effects of metformin on the histology and proliferation of the endometrium in women with endometrial cancer.
- To assess the effect of body mass index on the response to treatment with metformin
- To assess the effect of insulin resistance on the response to treatment with metformin
- To determine effects of metformin on the serum, urine and DNA biomarkers of women with endometrial cancer.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Metformin||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer|
|Actual Study Start Date :||September 16, 2010|
|Actual Primary Completion Date :||May 28, 2017|
|Actual Study Completion Date :||May 28, 2017|
Metformin 850 mg by mouth once daily for at least 7 days, and up to 30 days before surgery.
850 mg by mouth once daily for at least 7 days, and up to 30 days before surgery.
- Number of Patients with Increase in s6K Expression [ Time Frame: 30 days ]Baseline expression of s6K measured using Western blots, which yield ordinal results (e.g. "weak", "moderate", "strong", etc.). After treatment with metformin, expression again observed, and the percent of patients who have an increase in expression will be calculated.
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): NCT01205672
|United States, Texas|
|Lyndon B. Johnson General Hospital|
|Houston, Texas, United States, 77026|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Pamela Soliman, MD||M.D. Anderson Cancer Center|