An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin
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|ClinicalTrials.gov Identifier: NCT01816659|
Recruitment Status : Terminated (Slow Accrual)
First Posted : March 22, 2013
Last Update Posted : November 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Carcinoma||Drug: Metformin ER||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Metformin + Colon Surgery
Patients randomized to Metformin-ER 500 mg once daily for one week and then escalation to 1000 mg/day for the duration of the trial. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.
Drug: Metformin ER
500 mg by mouth once daily, beginning the day after colonoscopy for one week, and then escalation to 1000 mg/day. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.
Other Name: Metformin
No Intervention: Colon Surgery Alone
Patients will not receive any study drug from the time of colonoscopy until surgery.
- Comparison of Ki-67 in Tumor Samples [ Time Frame: 2 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816659
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Patrick Lynch, MD, JD||M.D. Anderson Cancer Center|