NCT01550900

Brief Summary

The goal of this clinical research study is to learn if metformin extended release (ER) can prevent colonic adenomas from becoming cancerous. Metformin ER will be compared to a placebo. Metformin ER is 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. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

7 years

First QC Date

March 8, 2012

Last Update Submit

April 4, 2013

Conditions

Colorectum

Keywords

ColorectumMetachronous ctalColonic Neoplastic PolypsChemopreventionColonic adenoma(s)Pre-cancerous tumor(s) on the colonMetformin ERExtended ReleasePlaceboSugar pill

Outcome Measures

Primary Outcomes (1)

  • Percentage of Ki-67-Stained Nuclei in Normal Rectal Mucosa

    Primary endpoint defined as change in overall proliferation index between baseline and first return visit, that is, percentage of Ki-67-stained nuclei, in normal rectal mucosa. Tissue samples will be obtained at baseline colonoscopy and subsequent exams for analysis including Ki67, caspase 3, and various biomarkers and immunohistochemicals studies.

    3 months

Study Arms (2)

Metformin ER

EXPERIMENTAL

Participants receive two tablets of Metformin ER 500 mg once daily for no more than twelve to eighteen months allowing time for at least one follow up colonoscopy. Dose will be reached in a gradual escalation scheme to improve gastrointestinal tolerance. If participants experience side effects during dose escalation regimen, they will be reduced to one tablet of 500 mg daily, and may continue taking 500 mg daily for the duration of the study.

Drug: Metformin ER

Placebo

ACTIVE COMPARATOR

Control group given matched Placebo once daily for no more than twelve to eighteen months allowing time for at least one follow up colonoscopy.

Other: Placebo

Interventions

Metformin ERDRUG

Starting dose: 500 mg by mouth daily for 1 week with weekly increases of 250 mg daily to target dose of 1000 mg daily.

Metformin ER
PlaceboOTHER

Placebo tablets by mouth 1 time a day.

Also known as: sugar pill
Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40 and 75 years
  • Polyp features suggesting high risk for recurrence include: piece-meal polypectomy, large (\>10mm) neoplastic polyp, polyp with high grade dysplasia, or substantial number (\>10) of neoplastic polyps.
  • ability to give informed consent
  • Patients should be registered on LAB10-0417
  • Diabetic patients are eligible but they may be excluded if they are taken Metformin, insulin or sulfonylureas

You may not qualify if:

  • Patients with renal insufficiency defined as serum creatinine \>= 1.4 mg/dl for females and \>= 1.5 mg/dl for males by the manufacturer.
  • 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
  • Liver dysfunction including chronic active hepatitis and cirrhosis
  • Inability to give informed consent
  • Other investigational drugs within the past one year or concurrently
  • Known hypersensitivity or intolerance to Metformin
  • Contraindications for repeat colonoscopy
  • Inflammatory bowel disease
  • Rectosigmoiditis of any etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

MetforminSugars

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsCarbohydrates

Study Officials

  • William Ross, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 12, 2012

Study Start

July 1, 2013

Primary Completion

July 1, 2020

Last Updated

April 5, 2013

Record last verified: 2013-04