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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
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Colorectal Carcinoma Drug: Metformin ER Phase 1

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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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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 Name: Metformin

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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Patrick Lynch, MD, JD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01816659     History of Changes
Other Study ID Numbers: 2012-1150
NCI-2013-00994 ( Registry Identifier: NCI CTRP )
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: August 2014
Keywords provided by M.D. Anderson Cancer Center:
Colorectal Carcinoma
Endoscopically Non- Resectable Adenomas
Colonic lesion
Biomarker
Metformin-ER
Metformin
Extended release
Colonoscopy
Colon cancer surgery
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs