An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied.

Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is also designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Age between 18- 75 years

2. Colonic lesion that should be removed surgically:

3. 2.a. CRC that is potentially resectable and not requiring neoadjuvant treatment.

4. 2.b. Endoscopically non-resectable adenoma.

5. 2.c. Familial Adenomatous Polyposis (FAP) patient that requires colectomy or proctocolectomy.

6. Need for perioperative colonoscopy as a part of standard of care evaluation:

7. 6.a. CRC or adenoma for which the colorectal surgeon requires a preoperative colonoscopy or sigmoidoscopy for any reason, including but not limited to:

8. 6.a.a. No outside colonoscopy

9. 6.a.b. No outside pathology

10. 6.a.c. Partially obstructing tumor or

11. 6.a.d. Otherwise unsatisfactory outside colonoscopy

12. 6.a.e. Rectal cancer requiring EUS

13. 6.a.f. Second opinion on adenoma regarded as endoscopically non-resectable on outside colonoscopy; or

14. 6.b. Patient found on initial MDACC colonoscopy to have CRC or endoscopically non-resectable adenoma, most commonly patients undergoing average or high risk (familial, history of adenoma) screening colonoscopy.

15. Ability to give informed consent.

16. Diabetic patients are eligible but they may be excluded if they are taking Metformin, insulin or sulfonylureas.

Exclusion Criteria:

1. Patients with renal insufficiency defined as serum creatinine >= 1.4 mg/dl for females and >= 1.5 mg/dl for males

2. Pregnant or nursing women

3. A malignancy currently under active therapy

4. Unstable angina

5. Uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification)

6. Current usage of Metformin

7. Current usage of insulin, sulfonylureas

8. History of lactic acidosis

9. Chronic liver disease or cirrhosis

10. Inability to give informed consent

11. Other investigational drugs within the past one year or concurrently

12. Known hypersensitivity or intolerance to Metformin