Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 5/27/2013 |
| Start Date: | August 2011 |
| End Date: | December 2013 |
| Contact: | Robin Millis, RN, BSN |
| Email: | rmillis@tuftsmedicalcenter.org |
| Phone: | 617-636-9161 |
Randomized Clinical Trial Evaluating the Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
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.
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
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