NCT01816659

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 18, 2015

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

March 20, 2013

Last Update Submit

November 16, 2015

Conditions

Colorectal Carcinoma

Keywords

Colorectal CarcinomaEndoscopically Non- Resectable AdenomasColonic lesionBiomarkerMetformin-ERMetforminExtended releaseColonoscopyColon cancer surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Study Arms (2)

Metformin + Colon Surgery

EXPERIMENTAL

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

Colon Surgery Alone

NO INTERVENTION

Patients will not receive any study drug from the time of colonoscopy until surgery.

Interventions

Metformin ERDRUG

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
Metformin + Colon Surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18- 75 years
  • Colonic lesion that should be removed surgically:
  • a. CRC that is potentially resectable and not requiring neoadjuvant treatment.
  • b. Endoscopically non-resectable adenoma.
  • c. Familial Adenomatous Polyposis (FAP) patient that requires colectomy or proctocolectomy.
  • Need for perioperative colonoscopy as a part of standard of care evaluation:
  • a. CRC or adenoma for which the colorectal surgeon requires a preoperative colonoscopy or sigmoidoscopy for any reason, including but not limited to:
  • a.a. No outside colonoscopy
  • a.b. No outside pathology
  • a.c. Partially obstructing tumor or
  • a.d. Otherwise unsatisfactory outside colonoscopy
  • a.e. Rectal cancer requiring EUS
  • a.f. Second opinion on adenoma regarded as endoscopically non-resectable on outside colonoscopy; or
  • 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.
  • +1 more criteria

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Patrick Lynch, MD, JD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 18, 2015

Record last verified: 2014-08

Locations

US(1)