Clincosm LogoSign in Get a demo

Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers

Sponsor
Tufts Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01440127
Collaborator
(none)
9
Enrollment
1
Location
2
Arms
14
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Metformin is drug that is normally used to treat people with diabetes. New research has discovered that metformin may also kill cancer stem cells. These cancer stem cells make up only a small portion of a cancer, but may be responsible for resistance to chemotherapy or for causing recurrence of the cancer. The purpose of this study is to determine the effect of metformin on colorectal cancer tumors. The study is designed to develop the methods to test tumors for cancer stem cells and then to determine the difference between treating with metformin and not treating with metformin with regard to the cancer stem cells. This research is investigational because the effect of metformin on cancer stem cells is not known in humans. Also, in patients who are not diabetic, metformin would normally not be given prior to surgery.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Clinical Trial Evaluating the Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metformin

Subjects in this arm are randomized to receive metformin during the period of time between planning the surgery or biopsy and the actual procedure. After approximately 1 week of taking metformin, we will re-check the blood glucose. We will draw blood for cancer stem cells (about 2 teaspoons) and ask about symptoms. Subjects will stop taking metformin 2 days before the procedure.

Drug: Metformin
Pills will be taken for one week prior to the scheduled surgery or biopsy procedure.
Other Names:
  • Fortamet
  • Glucophage
  • Glumetza
  • Riomet

    		•
    No Intervention: Observation

    No metformin will be given prior to the scheduled surgery or biopsy.

    Outcome Measures

    Primary Outcome Measures

    1. Expression of CD133 in tumors from patients treated or not treated with metformin [2-weeks of metformin treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically documented colorectal cancer

    • Intent to undergo disease resection or biopsy at least 7days from the treatment start date (allowing for a minimum of 5 days of treatment plus 2 days break)

    • Medically fit for resection of their primary tumor or for biopsy

    • Age 18-79 years

    • Adequate renal function (serum creatinine levels <1.5 mg/dL [males], <1.4 mg/dL [females] or estimated creatinine clearance >= 60 ml/min)

    • Adequate hepatic parameters, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, and alkaline phosphatase levels ≤ 2.5 x ULN

    • Ability to understand and willingness to sign a written informed consent document

    Exclusion Criteria:

    • Intent to administer neoadjuvant chemotherapy or radiation therapy prior to the surgery or biopsy;

    • Intent to perform surgery or biopsy within 7 days of study treatment start;

    • Any situation where participation in this trial would alter, or cause significant risk of altering the ability or timing of a subject to undergo resection of their tumor

    • Current use of metformin (within the past month);

    • Blood glucose using point of care test < 70mg/dl;

    • Renal disease or renal dysfunction not meeting inclusion criteria;

    • Significant medical conditions such as cardiovascular collapse (shock), acute myocardial infarction, septicemia, acute or chronic metabolic acidosis

    • History of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), conditions associated with hypoxemia and pancreatitis

    • Severe dehydration

    • Clinical or laboratory evidence of hepatic disease

    • Congestive heart failure requiring pharmacologic treatment, or unstable or acute congestive heart failure

    • Known hypersensitivity to metformin hydrochloride

    • Pregnant or lactating women

    • Psychiatric illness or social situation that would limit compliance with study requirements and/or obscure results

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tufts Medical Center Boston Massachusetts United States 02111

    Sponsors and Collaborators

    • Tufts Medical Center

    Investigators

    • Principal Investigator: Wasif Saif, MD, Tufts Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tufts Medical Center
    ClinicalTrials.gov Identifier:
    NCT01440127
    Other Study ID Numbers:
    • Metformin CCSC
    First Posted:
    Sep 26, 2011
    Last Update Posted:
    Mar 26, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Metformin

    Study Results

    No Results Posted as of Mar 26, 2015