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

Stopped early · Phase 1

Conditions studied: Colorectal Carcinoma

In brief

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.

Key facts

Study ID

NCT01816659

Run by

M.D. Anderson Cancer Center

People needed

3

Starts

2013-05-01

Expected to finish

2014-08-01

Last updated by the study team

2015-11-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18- 75 years
• Colonic lesion that should be removed surgically:
• 2.a. CRC that is potentially resectable and not requiring neoadjuvant treatment.
• 2.b. Endoscopically non-resectable adenoma.
• 2.c. Familial Adenomatous Polyposis (FAP) patient that requires colectomy or proctocolectomy.
• Need for perioperative colonoscopy as a part of standard of care evaluation:
• 6.a. CRC or adenoma for which the colorectal surgeon requires a preoperative colonoscopy or sigmoidoscopy for any reason, including but not limited to:
• 6.a.a. No outside colonoscopy
• 6.a.b. No outside pathology
• 6.a.c. Partially obstructing tumor or
• 6.a.d. Otherwise unsatisfactory outside colonoscopy
• 6.a.e. Rectal cancer requiring EUS
• 6.a.f. Second opinion on adenoma regarded as endoscopically non-resectable on outside colonoscopy; or
• 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.
• Ability to give informed consent.
• Diabetic patients are eligible but they may be excluded if they are taking Metformin, insulin or sulfonylureas.

You may not qualify if…

• Patients with renal insufficiency defined as serum creatinine >= 1.4 mg/dl for females and >= 1.5 mg/dl for males
• Pregnant or nursing women
• A malignancy currently under active therapy
• Unstable angina
• Uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification)
• Current usage of Metformin
• Current usage of insulin, sulfonylureas
• History of lactic acidosis
• Chronic liver disease or cirrhosis
• Inability to give informed consent
• Other investigational drugs within the past one year or concurrently
• Known hypersensitivity or intolerance to Metformin

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.