TerminatedNCT01816659Updated Nov 18, 2015

An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin

A Phase 1 interventional study of Metformin ER in Colorectal Carcinoma, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-11-18.

Sponsored by M.D. Anderson Cancer Center · Phase 1 and Interventional

Why this study was terminated

Slow Accrual

Phase: Phase 1
Study type: Interventional
Enrollment: 3
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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 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.

Read the 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 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 (or later if your surgery is scheduled to be more than 30 days after the colonoscopy) and will continue to take it until your scheduled surgery (for up to 30 days). 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 until surgery.

Study Visits:

On the day of your colonoscopy:

Your medical history will be recorded and you will be asked about any drugs you may be taking.
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:

Your weight will be measured.
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 having.
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 study directions.

Your participation on the study will be over once you have had the surgery.

This is an investigational study. Metformin-ER is 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.

Conditions studied

Colorectal Carcinoma

Browse trials for

Colorectal Neoplasms 5,598

Keywords

Colorectal Carcinoma
Endoscopically Non- Resectable Adenomas
Colonic lesion
Biomarker
Metformin-ER
Metformin
Extended release
Colonoscopy
Colon cancer surgery

In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 3 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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 criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 3 participants (actual)

Study arms

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
No intervention
Colon Surgery Alone
Patients will not receive any study drug from the time of colonoscopy until surgery.

Interventions

DrugMetformin 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.
Also known as: Metformin

What researchers measure

Primary outcomes

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.
Time frame: 2 weeks

Study locations

1 site

University of Texas MD Anderson Cancer Center
Houston, Texas 77030, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01816659
Lead sponsor: M.D. Anderson Cancer Center
Responsible party: Sponsor
First posted: Mar 22, 2013
Start date: May 2013
Primary completion: Aug 2014
Completion: Aug 2014
Last update: Nov 18, 2015

Study contacts

Patrick Lynch, MD, JD

principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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