A Trial of Metformin for Colorectal Cancer Risk Reduction Among Patients With a History of Colorectal Adenomas and Elevated Body Mass Index

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01312467
First received: March 7, 2011
Last updated: June 3, 2015
Last verified: June 2014
Results First Received: May 11, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Adenomatous Polyp
Colorectal Cancer
Obesity
Interventions: Drug: metformin hydrochloride
Other: pharmacological study
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between 2011 and 2013, 45 obese colorectal adenoma (CRA) patients were enrolled at three study sites: UC Irvine, Long Beach VAMC, and Kaiser Permanente, Sacramento).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Prevention (Metformin Hydrochloride)

Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.

metformin hydrochloride: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Prevention (Metformin Hydrochloride)  
STARTED     45  
COMPLETED     32  
NOT COMPLETED     13  
Adverse Event                 4  
Lost to Follow-up                 1  
Withdrawal by Subject                 2  
Deported to country of origin                 1  
Another medical condition                 1  
Ineligible                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
45 participants were enrolled into the study

Reporting Groups
  Description
Prevention (Metformin Hydrochloride)

Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.

metformin hydrochloride: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Prevention (Metformin Hydrochloride)  
Number of Participants  
[units: participants]
  45  
Age  
[units: years]
Mean (Standard Deviation)
  59.6  (6.83)  
Gender  
[units: participants]
 
Female     15  
Male     30  
Region of Enrollment  
[units: participants]
 
United States     45  
Canada     0  



  Outcome Measures

1.  Primary:   Change in Activated S6serine235 (i.e., the Ratio of pS6serine235/S6serine235)   [ Time Frame: From baseline to 12 weeks ]

2.  Secondary:   Effects of Metformin Hydrochloride on Colorectal Mucosa Proliferation (Ki-67, Phosphorylated IGF-1 Receptor, Phosphorylated Insulin Receptor, Phosphorylated AKT, Phosphorylated mTOR, and Phosphorylated AMP Kinase)   [ Time Frame: Up to 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Effects of Metformin Hydrochloride on Serum (Fasting and 2 Hour Postprandial Insulin and Glucose, Fasting IGF-1, IGFBP-1, IGFBP-3, Leptin, Adiponectin and Metformin Levels)   [ Time Frame: Up to 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Safety and Tolerability of Metformin Hydrochloride Treatment   [ Time Frame: Up to 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Frank L. Meyskens, Jr.
Organization: University of California, Irvine
phone: 714-456-6310
e-mail: flmeyske@uci.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01312467     History of Changes
Other Study ID Numbers: NCI-2011-01744, NCI-2011-01744, UCI 10-31, 2010-7705, UCI09-13-01, 2010-7705, UCI09-13-01, P30CA062203, N01CN35160
Study First Received: March 7, 2011
Results First Received: May 11, 2015
Last Updated: June 3, 2015
Health Authority: United States: Food and Drug Administration