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

Celecoxib for Chemoprevention of Primary Lung Cancer

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.

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