Prospective Trial of Metformin - Chemoprevention Role

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if metformin extended release (ER) can prevent colonic adenomas from becoming cancerous. Metformin ER will be compared to a placebo.

Metformin ER is 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.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

1. Age between 40 and 75 years

2. Polyp features suggesting high risk for recurrence include: piece-meal polypectomy, large (>10mm) neoplastic polyp, polyp with high grade dysplasia, or substantial number (>10) of neoplastic polyps.

3. ability to give informed consent

4. Patients should be registered on LAB10-0417

5. Diabetic patients are eligible but they may be excluded if they are taken 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 by the manufacturer.

2. Pregnant or nursing women

3. A malignancy currently under active therapy

4. Unstable angina, uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification)

5. Current usage of Metformin

6. Current usage of insulin, sulfonylureas

7. History of lactic acidosis

8. Liver dysfunction including chronic active hepatitis and cirrhosis

9. Inability to give informed consent

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

11. Known hypersensitivity or intolerance to Metformin

12. Contraindications for repeat colonoscopy

13. Inflammatory bowel disease

14. Rectosigmoiditis of any etiology