Status:
TERMINATED
Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
Lead Sponsor:
Tufts Medical Center
Conditions:
Colon Cancer
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01440127
Start Date
August 1 2011
End Date
October 1 2012
Last Update
March 26 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111