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

November 16, 2015 updated by: M.D. Anderson Cancer Center

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18- 75 years
  2. Colonic lesion that should be removed surgically:
  3. 2.a. CRC that is potentially resectable and not requiring neoadjuvant treatment.
  4. 2.b. Endoscopically non-resectable adenoma.
  5. 2.c. Familial Adenomatous Polyposis (FAP) patient that requires colectomy or proctocolectomy.
  6. Need for perioperative colonoscopy as a part of standard of care evaluation:
  7. 6.a. CRC or adenoma for which the colorectal surgeon requires a preoperative colonoscopy or sigmoidoscopy for any reason, including but not limited to:
  8. 6.a.a. No outside colonoscopy
  9. 6.a.b. No outside pathology
  10. 6.a.c. Partially obstructing tumor or
  11. 6.a.d. Otherwise unsatisfactory outside colonoscopy
  12. 6.a.e. Rectal cancer requiring EUS
  13. 6.a.f. Second opinion on adenoma regarded as endoscopically non-resectable on outside colonoscopy; or
  14. 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.
  15. Ability to give informed consent.
  16. Diabetic patients are eligible but they may be excluded if they are taking Metformin, insulin or sulfonylureas.

Exclusion Criteria:

  1. Patients with renal insufficiency defined as serum creatinine >= 1.4 mg/dl for females and >= 1.5 mg/dl for males
  2. Pregnant or nursing women
  3. A malignancy currently under active therapy
  4. Unstable angina
  5. Uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification)
  6. Current usage of Metformin
  7. Current usage of insulin, sulfonylureas
  8. History of lactic acidosis
  9. Chronic liver disease or cirrhosis
  10. Inability to give informed consent
  11. Other investigational drugs within the past one year or concurrently
  12. Known hypersensitivity or intolerance to Metformin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Metformin
NO_INTERVENTION: Colon Surgery Alone
Patients will not receive any study drug from the time of colonoscopy until surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (ESTIMATE)

March 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-1150
  • NCI-2013-00994 (REGISTRY: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Carcinoma

Clinical Trials on Metformin ER

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe