Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers

OBJECTIVES:

- 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.

Inclusion Criteria:

- Age > 45

- Smoked > 20 pack years

Exclusion Criteria:

- 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

- Pregnancy

- 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