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
PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell
lung cancer in tobacco smokers.
- 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.
- Age > 45
- Smoked > 20 pack years
- Concurrent use of NSAIDs
- Hypersensitivity to celecoxib
- Documented allergic-type reaction to sulfonamides
- History of allergic reaction, urticaria or asthma to aspirin or other NSAIDs
- History of liver dysfunction
- Hypertension or cardiac conditions aggravated by fluid retention and edema
- Previous history of gastrointestinal ulceration, bleeding, or perforation
- Renal dysfunction
- End stage respiratory disease
- Unstable angina
- Other malignancy
- Concurrent use of medication known to alter or be affected by alteration of the
hepatic p450 2C9 and 2D6 enzymes
- Patents with concurrent medical conditions that may interfere with completion of
tests, therapy, or the follow up schedule