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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01440127
Recruitment Status : Terminated (Unable to accrue all planned subjects in a timely fashion, but data collected will still be analyzed.)
First Posted : September 26, 2011
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Tufts Medical Center

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
Colon Cancer Drug: Metformin Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Expression of CD133 in tumors from patients treated or not treated with metformin [ Time Frame: 2-weeks of metformin treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01440127

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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
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Principal Investigator: Wasif Saif, MD Tufts Medical Center
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Responsible Party: Tufts Medical Center Identifier: NCT01440127    
Other Study ID Numbers: Metformin CCSC
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Hypoglycemic Agents
Physiological Effects of Drugs