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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)


Phase 1
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Carcinoma

Thank you

Trial Information

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 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 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
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:

- 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
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 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Comparison of Ki-67 in Tumor Samples

Outcome Description:

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.

Outcome Time Frame:

2 weeks

Safety Issue:

Yes

Principal Investigator

Patrick Lynch, MD, JD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2012-1150

NCT ID:

NCT01816659

Start Date:

May 2013

Completion Date:

Related Keywords:

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

Name

Location

University of Texas MD Anderson Cancer CenterHouston, Texas  77030