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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
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
Enrollment 1
Recruitment Details Recruitment Period: September 29, 2005 to December 18, 2007. Patients were recruited at UT MD Anderson Cancer Center.
Pre-assignment Details One patient registered determined to be inevaluable. Trial termination due to poor accrual and study program redesign.
Arm/Group Title Celecoxib Treatment No Treatment
Hide Arm/Group Description Celecoxib 600 mg orally daily [Not Specified]
Period Title: Overall Study
Started 1 0
Completed 0 0
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Arm/Group Title Celecoxib Treatment No Treatment Total
Hide Arm/Group Description Celecoxib 600 mg orally daily [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 1 participants
<=18 years 0 0
Between 18 and 65 years 1 1
>=65 years 0 0
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female 1 1
Male 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Histological Responses
Hide Description Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis. One registered patient inevaluable for response, study terminated early.
Arm/Group Title Celecoxib Treatment No Treatment
Hide Arm/Group Description:
Celecoxib 600 mg orally daily
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 21 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib Treatment No Treatment
Hide Arm/Group Description Celecoxib 600 mg orally daily [Not Specified]
All-Cause Mortality
Celecoxib Treatment No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib Treatment No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Celecoxib Treatment No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Waun K. Hong, MD/Professor
Organization: UT MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov 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