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

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

Overview[ - collapse ][ - ]

Purpose	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	Colon Cancer
Intervention	Drug: Metformin
Phase	Phase 1
Sponsor	Tufts Medical Center
Responsible Party	Tufts Medical Center
ClinicalTrials.gov Identifier	NCT01440127
First Received	September 21, 2011
Last Updated	July 10, 2013
Last verified	July 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 21, 2011
Last Updated Date	July 10, 2013
Start Date	August 2011
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	Expression of CD133 in tumors from patients treated or not treated with metformin [Time Frame: 2-weeks of metformin treatment] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
Official Title	Randomized Clinical Trial Evaluating the Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Colon Cancer
Intervention	Drug: Metformin Pills will be taken for one week prior to the scheduled surgery or biopsy procedure. Other Names: Fortamet Glucophage Glumetza Riomet
Study Arm (s)	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. No Intervention: Observation No metformin will be given prior to the scheduled surgery or biopsy.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	9
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01440127
Other Study ID Numbers	Metformin CCSC
Has Data Monitoring Committee	Yes
Information Provided By	Tufts Medical Center
Study Sponsor	Tufts Medical Center
Collaborators	Not Provided
Investigators	Principal Investigator: Wasif Saif, MD Tufts Medical Center
Verification Date	July 2013

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