Status:
COMPLETED
Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
American Cancer Society, Inc.
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-80 years
Phase:
EARLY_PHASE1
Brief 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 effect...
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 ...
Eligibility Criteria
Inclusion
- Patients must have signed informed consent
- Patients must have histologically-confirmed endometrial adenocarcinoma, any grade (1, 2, or 3) or a mixed tumor with at least an endometrioid component
- Patients must be a candidate for surgical staging procedure
- Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months
- Patients must have a documented non-fasting plasma glucose level of less than or equal to 125 mg/dL. If non-fasting plasma glucose is greater than125 mg/dL, patients must have a fasting plasma glucose level less than or equal to 125 mg/dL
- Patients must have an adequated renal function of \>60cc/min as documented by the Cockcroft Gualt creatinine clearance formula: (140 - age) x (weight Kg) DIVIDED BY Estimated GFR+ 72x serum Creatinine (non-IDMS x 85 (female)
- Patients must have adequate hepatic function as documented by a serum bilirubin \< 2.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor
Exclusion
- Patients with a known history of diabetes mellitus type 1 or 2 or currently taking any hypoglycemic agents
- Patients who have received metformin or another mTOR inhibitor in the last 2 years
- Patients with uterine sarcomas
- Patients who have received prior treatment for endometrial carcinoma with cytotoxic or biologic chemotherapy. Patients who have only received hormonal therapy for endometrial cancer may be included
- Patients who have undergone definitive surgery including hysterectomy or endometrial ablation
- Patients who are not surgical candidates
- Patients with a known hypersensitivity to metformin
- Patients with metabolic acidosis, acute or chronic, including ketoacidosis or increased risk of lactic acidosis
- Patients who have a history of excessive alcohol use
- Patients with a history of congestive heart failure requiring pharmacologic treatment
- Patients with a known history of HIV
- Patients older than 80 year of age
Key Trial Info
Start Date :
September 16 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01205672
Start Date
September 16 2010
End Date
May 28 2017
Last Update
June 2 2017
Active Locations (2)
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1
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030