Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
NCT ID: NCT01632020
Last Updated: 2016-07-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2012-08-31
2015-01-31
Brief Summary
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It is hypothesized that there are independent actions of Metformin on the outcome of subjects with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.
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Detailed Description
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Based upon epidemiological studies, it is hypothesized that there are independent actions of Metformin on the outcome of subjects with CRC. Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
Placebo
2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
Metformin
Metformin 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
Metformin
850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
Interventions
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Placebo
2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
Metformin
850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age equal to or greater than 18 years of age
* All subjects should have a pathological/histological diagnosis of colorectal cancer.
* Clinical diagnosis of stage I, II, III or IV colon cancer or stage I, II, III or IV rectal cancer; cancer may be primary including a secondary primary
* Candidate for elective surgery(for removal of primary) or endoscopic biopsy
* ECOG Performance status of 0 - 2
* Adequate renal, liver, and bone marrow function
* Hb: (adequate for surgical intervention, with transfusion if necessary)
* WBC: (normal range)
* Platelets: (180K/cmm)
* LFTs: Normal bilirubin (\< 2.0mg/dL), AST/ALT (2xULN)
* Renal function: normal creatinine
* Subjects must have signed informed consent
* Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of beginning the drug or placebo treatment. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.
Exclusion Criteria
* Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR inhibitors or having taken any of these medications during the 12 weeks prior to study participation.
* Currently taking any non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin and unable to stop such medications due to a present medical condition.
* Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation.
* Familial Adenomatous Polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.
* Pregnant or lactating.
* History of lactic or other metabolic acidosis.
* Known hypersensitivity to Metformin.
* Uncontrolled infectious disease.
* History of Positivity for human immunodeficiency virus (HIV).
* History of congestive heart failure requiring pharmacologic treatment.
* History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily.
* Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for \> 5 years, with the exception of prior CRC which has been treated and the patient has been in remission and the current primary tumor is a second CRC.
* Unable to swallow and retain oral medication.
* Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
* Current use of medications for weight loss.
* Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted.
* If the physician feels that the candidate is not suitable for the study, he/she will be excluded.
18 Years
ALL
No
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Rangaswamy Govindarajan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Frank Simmen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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Central Arkansas Veterans Heathcare System
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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134190
Identifier Type: -
Identifier Source: org_study_id
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