NCT01632020

Brief Summary

The purpose of this study is to investigate the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma. It is hypothesized that there are independent actions of Metformin on the outcome of subjects with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

2 active sites

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

June 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

May 1, 2016

Enrollment Period

2.4 years

First QC Date

June 27, 2012

Results QC Date

February 19, 2016

Last Update Submit

May 31, 2016

Conditions

Colorectal Neoplasms

Keywords

colorectal tumorcolorectal cancercolorectal carcinomaneoplasms, colorectalMetformin

Outcome Measures

Primary Outcomes (2)

  • Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy

    10-21 days

  • Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy

    10-21 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days

Drug: Placebo

Metformin

ACTIVE COMPARATOR

Metformin 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days

Drug: Metformin

Interventions

PlaceboDRUG

2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days

Also known as: inactive drug
Placebo
MetforminDRUG

850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days

Also known as: Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet
Metformin

Eligibility Criteria

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

You may qualify if:

  • Male or female, all races and ethnicities are eligible
  • Age equal to or greater than 18 years of age
  • All subjects should have a pathological/histological diagnosis of colorectal cancer.
  • Clinical diagnosis of stage I, II, III or IV colon cancer or stage I, II, III or IV rectal cancer; cancer may be primary including a secondary primary
  • Candidate for elective surgery(for removal of primary) or endoscopic biopsy
  • ECOG Performance status of 0 - 2
  • Adequate renal, liver, and bone marrow function
  • Hb: (adequate for surgical intervention, with transfusion if necessary)
  • WBC: (normal range)
  • Platelets: (180K/cmm)
  • LFTs: Normal bilirubin (\< 2.0mg/dL), AST/ALT (2xULN)
  • Renal function: normal creatinine
  • Subjects must have signed informed consent
  • Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of beginning the drug or placebo treatment. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.

You may not qualify if:

  • Previously diagnosed with diabetes mellitus Type 1 or Type 2.
  • Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR inhibitors or having taken any of these medications during the 12 weeks prior to study participation.
  • Currently taking any non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin and unable to stop such medications due to a present medical condition.
  • Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation.
  • Familial Adenomatous Polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.
  • Pregnant or lactating.
  • History of lactic or other metabolic acidosis.
  • Known hypersensitivity to Metformin.
  • Uncontrolled infectious disease.
  • History of Positivity for human immunodeficiency virus (HIV).
  • History of congestive heart failure requiring pharmacologic treatment.
  • History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily.
  • Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for \> 5 years, with the exception of prior CRC which has been treated and the patient has been in remission and the current primary tumor is a second CRC.
  • Unable to swallow and retain oral medication.
  • Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Arkansas Veterans Heathcare System

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

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

Limitations and Caveats

Early termination leading to small numbers of subjects. Outcome measures not computed because data would not be statistically relevant.

Results Point of Contact

Title
Daisy Wade
Organization
University of Arkansas for Medical Sciences
dewade@uams.edu
5016868274

Study Officials

  • Rangaswamy Govindarajan, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

  • Frank Simmen, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

June 29, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 11, 2016

Results First Posted

July 11, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)