Status:
TERMINATED
An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 saf...
Detailed Description
Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. * If you are in Group 1, you will receive metform...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01816659
Start Date
May 1 2013
End Date
August 1 2014
Last Update
November 18 2015
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030