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Trial record 49 of 229 for:    metformin and cancer AND Hypoglycemic

Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth

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ClinicalTrials.gov Identifier: NCT01632020
Recruitment Status : Terminated (Inadequate accrual)
First Posted : June 29, 2012
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE June 27, 2012
First Posted Date  ICMJE June 29, 2012
Results First Submitted Date  ICMJE February 19, 2016
Results First Posted Date  ICMJE July 11, 2016
Last Update Posted Date July 11, 2016
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
  • Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy [ Time Frame: 10-21 days ]
  • Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy [ Time Frame: 10-21 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
  • Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy [ Time Frame: 14-21 days ]
  • Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy [ Time Frame: 14-21 days ]
Change History Complete list of historical versions of study NCT01632020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
  • Blood glucose and hormone profile levels before and after Metformin therapy [ Time Frame: 14-21 days ]
  • Blood lipid profiles before and after Metformin therapy [ Time Frame: 14-21 days ]
  • CEA and HbA1c levels before and after Metformin therapy [ Time Frame: 14-21 days ]
  • Plasma miR and mRNA levels before and after Metformin therapy [ Time Frame: 14-21 days ]
  • Tumor and mucosal miR and mRNA levels following Metformin therapy [ Time Frame: 14-21 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
Official Title  ICMJE Pilot Study: Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
Brief Summary

The purpose of this study is to investigate the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma.

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.

Detailed Description

This is a randomized, double-blinded placebo controlled clinical investigation of the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma. Metformin is a well-tolerated drug widely prescribed for treatment of Type 2 diabetes mellitus. Preliminary studies have generated the hypothesis that metformin may have positive effects on both prevention and survival of colon cancer subjects. Clinical trials are ongoing to explore this possibility in breast cancer (NCT01101438). This investigation is the first study of Metformin in colorectal cancer (CRC) patients, and is designed to understand the mechanism of its anti-cancer actions, if any, and its interactions with biomarkers in colorectal cancer patients.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • Drug: Placebo
    2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
    Other Name: inactive drug
  • Drug: Metformin
    850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
    Other Names:
    • Glucophage
    • Glucophage XR
    • Glumetza
    • Fortamet
    • Riomet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
    Intervention: Drug: Placebo
  • Active Comparator: Metformin
    Metformin 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
    Intervention: Drug: Metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2016)
7
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2012)
40
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, all races and ethnicities are eligible
  • 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:

  • Previously diagnosed with diabetes mellitus Type 1 or Type 2.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01632020
Other Study ID Numbers  ICMJE 134190
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rangaswamy Govindarajan, MD University of Arkansas
Principal Investigator: Frank Simmen, PhD University of Arkansas
PRS Account University of Arkansas
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP