Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this research study is to learn if metformin can affect endometrial cancer cells
      in women who do not have diabetes.

      Objectives:

      Primary Objectives:

      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

      Secondary Objectives:

        1. To describe the effects of metformin on the histology and proliferation of the
           endometrium in women with endometrial cancer.

        2. To assess the effect of body mass index on the response to treatment with metformin

        3. To assess the effect of insulin resistance on the response to treatment with metformin

        4. To determine effects of metformin on the serum, urine and DNA biomarkers of women with
           endometrial cancer.
    

Detailed description: 
      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.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): 850 mg by mouth once daily for at least 7 days, and up to 30 days before surgery.
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometrium; Gynecologic malignancy; Endometrial adenocarcinoma; Insulin/glucose metabolism; Metformin