Pilot Study: Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
This is a randomized, double-blinded placebo controlled clinical investigation of the
effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with
newly diagnosed colon or rectal adenocarcinoma. Metformin is a well-tolerated drug widely
prescribed for treatment of Type 2 diabetes mellitus. Preliminary studies have generated the
hypothesis that metformin may have positive effects on both prevention and survival of colon
cancer subjects. Clinical trials are ongoing to explore this possibility in breast cancer
(NCT01101438). This investigation is the first study of Metformin in colorectal cancer (CRC)
patients, and is designed to understand the mechanism of its anti-cancer actions, if any,
and its interactions with biomarkers in colorectal cancer patients.
Based upon epidemiological studies, it is hypothesized that there are independent actions of
Metformin on the outcome of subjects with CRC. Also hypothesized is that metformin effects
on CRC cell growth will correlate with this drug's effects on markers mentioned above,
because the markers are closely related to tumor growth and metastases.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Proliferation status of CRC tumor and adjacent normal tissue following Metformin therapy
10-21 days
No
Rangaswamy Govindarajan, MD
Principal Investigator
University of Arkansas
United States: Institutional Review Board
134190
NCT01632020
August 2012
July 2014
Name | Location |
---|---|
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Central Arkansas Veterans Heathcare System | Little Rock, Arkansas 72205 |