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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00527982
Recruitment Status : Terminated (Termination due to poor accrual.)
First Posted : September 11, 2007
Results First Posted : April 20, 2011
Last Update Posted : December 6, 2012
United States Department of Defense
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Head and Neck Cancer
Lung Cancer
Intervention: Drug: Celecoxib

  Participant Flow

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
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 
Physician Decision                1                0 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 1   0   1 
[Units: Years]
<=18 years   0      0 
Between 18 and 65 years   1      1 
>=65 years   0      0 
[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

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

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

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00527982     History of Changes
Other Study ID Numbers: 2004-0104
First Submitted: September 10, 2007
First Posted: September 11, 2007
Results First Submitted: January 6, 2011
Results First Posted: April 20, 2011
Last Update Posted: December 6, 2012