Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Celecoxib for Chemoprevention of Primary Lung Cancer|
- Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2 [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
- Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment [ Time Frame: 6 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2001|
|Study Completion Date:||May 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
See intervention description.
Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
Other Name: Celebrex
- Determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers.
- Determine the safety and long-term side effects of this drug in this population.
OUTLINE: Patients receive oral celecoxib twice daily for 6 months.
Patients are followed at 2 weeks and then at 6 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020878
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Jenny T. Mao, MD||Jonsson Comprehensive Cancer Center|