Know Cancer

forgot password

Randomized Clinical Trial Evaluating the Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers

Phase 1
18 Years
79 Years
Open (Enrolling)
Colon Cancer

Thank you

Trial Information

Randomized Clinical Trial Evaluating the Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Expression of CD133 in tumors from patients treated or not treated with metformin

Outcome Time Frame:

2-weeks of metformin treatment

Safety Issue:


Principal Investigator

Wasif Saif, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts Medical Center


United States: Institutional Review Board

Study ID:

Metformin CCSC



Start Date:

August 2011

Completion Date:

December 2013

Related Keywords:

  • Colon Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms



Tufts Medical CenterBoston, Massachusetts  02111