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Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung Cancer

This study has been terminated.
(Termination due to poor accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00527982
First received: September 10, 2007
Last updated: December 4, 2012
Last verified: December 2012
Results First Received: January 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Head and Neck Cancer
Lung Cancer
Intervention: Drug: Celecoxib

  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
Recruitment Period: September 29, 2005 to December 18, 2007. Patients were recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient registered determined to be inevaluable. Trial termination due to poor accrual and study program redesign.

Reporting Groups
  Description
Celecoxib Treatment Celecoxib 600 mg orally daily
No Treatment No text entered.

Participant Flow:   Overall Study
    Celecoxib Treatment     No Treatment  
STARTED     1     0  
COMPLETED     0     0  
NOT COMPLETED     1     0  
Physician Decision                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Celecoxib Treatment Celecoxib 600 mg orally daily
No Treatment No text entered.
Total Total of all reporting groups

Baseline Measures
    Celecoxib Treatment     No Treatment     Total  
Number of Participants  
[units: participants]
  1     0     1  
Age  
[units: years]
     
<=18 years     0         0  
Between 18 and 65 years     1         1  
>=65 years     0         0  
Gender  
[units: participants]
     
Female     1         1  
Male     0         0  
Region of Enrollment  
[units: participants]
     
United States     1         1  



  Outcome Measures

1.  Primary:   Histological Responses   [ Time Frame: Baseline to 12 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Waun K. Hong, MD/Professor
Organization: UT MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00527982     History of Changes
Other Study ID Numbers: 2004-0104
Study First Received: September 10, 2007
Results First Received: January 6, 2011
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board