An Open-Labeled Pilot Study of Biomarker Response in Patients With Colorectal Cancer or Endoscopically Non-Resectable Adenomas Following Short-Term Exposure to Metformin Extended Release (ER)
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 metformin ER. You will have a 2 in 3 chance of
being assigned to Group 1.
- If you are in Group 2, you will receive no treatment. You will have a 1 in 3 chance of
being assigned to Group 2.
Study Drug Administration:
If you are in Group 1, You will start taking the drug the day after your colonoscopy and
will continue to take it until your scheduled surgery. During the first week you will take
one tablet of metformin-ER by mouth one time each day with food. From the beginning of the
second week until your scheduled surgery, you will take two tablets of metformin-ER by mouth
one time each day with food. If you have side effects, your dose may be lowered.
If you are in Group 2, you will not receive any study drug from the time of your colonoscopy
On the day of your colonoscopy:
- Your medical history will be recorded and you will be asked about any drugs you may be
- You will have a physical exam.
- Extra tissue samples will be collected during the colonoscopy for routine and biomarker
testing. Biomarkers are small pieces of material or substances found in you tissue that
may provide information about your condition or the disease.
The study staff will call you 1 week after your colonoscopy and ask about your general
health and about any side effects you may be having.
On the day before surgery or the day of the surgery itself:
- You will have a physical exam, including measurement of your weight.
- Blood (about 3 tablespoons) will be drawn for routine tests and for research about the
safety of metformin-ER and how it may affect the disease. This routine blood draw will
include a pregnancy test if you are able to become pregnant.
- You will be asked about your general health and about any side effects you may be
- During the surgery, extra tissue samples will be collected for biomarker testing.
Length of Study:
You will be on study for up to 30 days. You will no longer be able to take the study drug
if the disease gets worse, if intolerable side effects occur, or if you are unable to follow
Your participation on the study will be over once you have had the surgery.
This is an investigational study. Metformin-ER if FDA approved and commercially available
for the treatment of type 2 diabetes. Its use in this study is investigational.
Up to 23 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Comparison of Ki-67 in Tumor Samples
Primary outcome measure is change in the percentage of Ki67-positive-staining cells between the baseline colonoscopy and surgery in the colon rectal cancer/non-resectable adenoma samples.
Patrick Lynch, MD, JD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|