Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00118365
First received: July 8, 2005
Last updated: January 12, 2015
Last verified: February 2014
Results First Received: April 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Precancerous Condition
Interventions: Other: placebo
Drug: eflornithine
Drug: sulindac
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
No text entered.

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
Arm I (Eflornithine and Sulindac)

Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

eflornithine: Given orally

sulindac: Given orally

laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

placebo: Given orally

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Arm I (Eflornithine and Sulindac)     Arm II (Placebo)  
STARTED     191     184  
COMPLETED     132     124  
NOT COMPLETED     59     60  



  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.
Randomized participants

Reporting Groups
  Description
Arm I (Eflornithine and Sulindac)

Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

eflornithine: Given orally

sulindac: Given orally

laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Arm I (Eflornithine and Sulindac)     Arm II (Placebo)     Total  
Number of Participants  
[units: participants]
  191     184     375  
Age  
[units: years]
Mean (Standard Deviation)
  60  (8.6)     61  (8.4)     60.5  (8.40)  
Gender  
[units: participants]
     
Female     44     46     90  
Male     147     138     285  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Detection of Any Adenoma at the End of the Study   [ Time Frame: Up to 36 months ]

2.  Secondary:   Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment   [ Time Frame: Up to 36 months ]

3.  Secondary:   Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment   [ Time Frame: Up 36 months ]

4.  Secondary:   Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment   [ Time Frame: Up 36 months ]

5.  Secondary:   Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment   [ Time Frame: Up to 36 months ]

6.  Secondary:   Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment   [ Time Frame: Up to 36 months ]

7.  Secondary:   Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment   [ Time Frame: Up to 36 months ]

8.  Secondary:   Adverse Events With a Grade of 3 and Above   [ Time Frame: Up to 36 months ]

9.  Secondary:   Baseline Putrescine by ODC Genotype   [ Time Frame: Baseline ]

10.  Secondary:   Baseline Spermidine by ODC Genotype   [ Time Frame: Baseline ]

11.  Secondary:   Baseline Spermine by ODC Genotype   [ Time Frame: Baseline ]

12.  Secondary:   At the End of the Study - Putrescine Response by ODC Genotype   [ Time Frame: At the end of the study ]

13.  Secondary:   At the End of the Study - Spermidine Response by ODC Genotype   [ Time Frame: At the end of the study ]

14.  Secondary:   At the End of the Study - Spermine Response by ODC Genotype   [ Time Frame: At the end of the study ]

15.  Secondary:   Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group   [ Time Frame: Up to 36 months ]

16.  Secondary:   Biomarker in Adenoma: Apoptosis   [ Time Frame: At the end of the study ]

17.  Secondary:   Biomarker in Adenoma - Ki-67   [ Time Frame: At the end of the study ]

18.  Secondary:   Biomarker in Adenoma: CEA   [ Time Frame: At the end of the study ]

19.  Secondary:   Biomarker in Adenoma: Sialyl-TN (B72.3)   [ Time Frame: At the end of the study ]

20.  Secondary:   Biomarker in Adenoma - p53   [ Time Frame: At the end of the study ]

21.  Secondary:   Biomarker in Adenoma: Bcl-2   [ Time Frame: At the end of the study, up to 3 years ]


  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
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  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 Meyskens, Jr.
Organization: University of California, Irvine
phone: 714-456-6310
e-mail: flmeyske@uci.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118365     History of Changes
Other Study ID Numbers: NCI-2009-00880
UCI 97-05
R01CA088078 ( US NIH Grant/Contract Award Number )
Study First Received: July 8, 2005
Results First Received: April 18, 2014
Last Updated: January 12, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government