Trial of Metformin for Colorectal Cancer Risk Reduction for History of Colorectal Adenomas and Elevated BMI

Completed · Phase 2

Conditions studied: Adenomatous Polyp, Colorectal Cancer, Obesity

In brief

The purpose of this study is to find out whether METFORMIN decreases protein markers in colorectal tissue. This is a phase IIA study of the pharmacodynamics, safety and tolerability of Metformin in decreasing colorectal mucosa in patients with a history of colorectal adenomas in the past 3 years and a BMI \>= 30, with decimals rounded to the nearest whole integer. Metformin as a potential chemopreventive agent for inhibition of the relevant molecular pathways involved in human colorectal carcinogenesis.

Key facts

Study ID

NCT01312467

Run by

National Cancer Institute (NCI)

People needed

45

Starts

2011-03-01

Expected to finish

2014-12-01

Last updated by the study team

2019-03-05

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of prior colorectal adenomas within the past 3 years; only patients who have had adenomas endoscopically removed are eligible; documentation of colorectal adenomas must be determined via review of pathology reports
• Body mass index (BMI) >= 30; rounded to the nearest whole integer
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Leukocytes ≥ 3,000/μL (>= 2,500/μL for African-American participants)
• Absolute neutrophil count >= 1,500/μL (>= 1,000/μL for African-American participants)
• Platelets >= 100,000/μL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 X institutional upper limit of normal (ULN)
• Creatinine within normal institutional limits
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• A serum pregnancy test must be performed and be negative in all women of childbearing potential within 2 weeks prior to starting treatment
• Ability to understand and willingness to sign a written informed consent document

You may not qualify if…

• History of colorectal cancer or other cancer(s) (except for non-melanoma skin cancers) within the last 3 years
• Family history of hereditary intestinal polyp disorder (e.g., familial adenomatous polyposis [FAP], hereditary non-polyposis colorectal cancer [HNPCC], Putz-Jegher's disease)
• Participants with diabetes
• History of vitamin B12 deficiency or megaloblastic anemia
• History of lactic acidosis
• Diet or other medications for weight loss
• Diseases associated with weight loss: anorexia, bulimia, or nausea
• Treatment with medications that may increase metformin levels: cationic drugs, e.g., digoxin, amiloride, procainamide, trimethoprim, vancomycin, triamterene, and morphine
• Treatment with other oral hypoglycemic agents
• Participants who have undergone full bowel resection, ablation or other local therapies
• Participants may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin
• Participants with human immunodeficiency virus (HIV), cirrhosis of any cause, NASH (nonalcoholic steatohepatitis), or hepatitis (auto-immune or infectious)
• Kidney disease or renal insufficiency (defined as serum creatinine > 1.4 mg/dL for females or > 1.5 mg/dL for males)
• Metabolic acidosis, acute or chronic, including ketoacidosis
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness/social situations that would limit compliance with study requirements
• Renal failure
• Hepatic failure
• Sepsis
• Hypoxia

Where it is running

• Veterans Administration Long Beach Medical Center — Long Beach, California, United States
• University of California Medical Center At Irvine-Orange Campus — Orange, California, United States
• Kaiser Permanente - Sacramento — Sacramento, California, United States
• Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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