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Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer

This study has been terminated.
(DSMB recommended closure of the protocol due to slow accrual.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steven Rosenberg, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00019747
First received: July 11, 2001
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
Results First Received: September 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: thalidomide
Procedure: adjuvant therapy
Other: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1 - Thalidomide Once Daily Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
Arm 2 - Placebo Once Daily Patients receive oral placebo once daily.

Participant Flow:   Overall Study
    Arm 1 - Thalidomide Once Daily     Arm 2 - Placebo Once Daily  
STARTED     23     16  
COMPLETED     23     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Arm 1 - Thalidomide Once Daily Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
Arm 2 - Placebo Once Daily Patients receive oral placebo once daily.
Total Total of all reporting groups

Baseline Measures
    Arm 1 - Thalidomide Once Daily     Arm 2 - Placebo Once Daily     Total  
Number of Participants  
[units: participants]
 		  23     16     39  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     12     7     19  
>=65 years     11     9     20  
Age  
[units: years]
Mean ± Standard Deviation 		  64.89  ± 8.70     71.19  ± 11.76     67.47  ± 10.54  
Gender  
[units: participants]
 		     
Female     8     7     15  
Male     15     9     24  
Ethnicity (NIH/OMB)  
[units: Participants]
 		     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     22     16     38  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     3     0     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     3     5  
White     17     13     30  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Hispanic     1     0     1  
Region of Enrollment  
[units: participants]
 		     
United States     23     16     39  



  Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: 62 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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 NOT 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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Steven A. Rosenberg, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-4164
e-mail: sar@mail.nih.gov


No publications provided


Responsible Party: Steven Rosenberg, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00019747     History of Changes
Other Study ID Numbers: 990102, 99-C-0102, CDR0000067098
Study First Received: July 11, 2001
Results First Received: September 25, 2012
Last Updated: November 7, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration