Metformin and Endometrial Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 28 January 2013
• Main ID: NCT01205672
• Date of registration: 17/09/2010
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: Metformin and Endometrial Cancer
• Scientific title: Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer
• Date of first enrolment: September 2010
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01205672
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Pamela Soliman, MD

• Name: Pamela Soliman, MD
• Affiliation: UT MD Anderson Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients must have signed informed consent

2. Patients must have histologically-confirmed endometrial adenocarcinoma, any grade (1,
2, or 3) or a mixed tumor with at least an endometrioid component

3. Patients must be a candidate for surgical staging procedure

4. 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

5. 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

6. 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)

7. 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 Criteria:

1. Patients with a known history of diabetes mellitus type 1 or 2 or currently taking
any hypoglycemic agents

2. Patients who have received metformin or another mTOR inhibitor in the last 2 years

3. Patients with uterine sarcomas

4. 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

5. Patients who have undergone definitive surgery including hysterectomy or endometrial
ablation

6. Patients who are not surgical candidates

7. Patients with a known hypersensitivity to metformin

8. Patients with metabolic acidosis, acute or chronic, including ketoacidosis or
increased risk of lactic acidosis

9. Patients who have a history of excessive alcohol use

10. Patients with a history of congestive heart failure requiring pharmacologic treatment

11. Patients with a known history of HIV

12. Patients older than 80 year of age



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Endometrial Cancer

Intervention(s)

Drug: Metformin

Primary Outcome(s)

Number of Patients with Increase in s6K Expression [Time Frame: 30 days]

Secondary ID(s)

2009-0927

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

American Cancer Society, Inc.