Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of oral leukoplakia with hyperplasia or dysplasia
• * Documented by baseline biopsy of oral lesions suspicious for leukoplakia
• * For patients using dentures over the past 6 months, only lesions located on the ventral-lateral tongue or floor of the mouth are allowed
• * No leukoplakia/hyperplasia secondary to mechanical irritation
• No carcinoma in situ of the oral cavity
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• Not specified
• Life expectancy
• At least 1 year
• Hematopoietic
• Hemoglobin ≥ 10 g/dL (women) OR ≥ 11 g/dL (men)
• Hepatic
• AST or ALT normal
• Bilirubin normal
• Renal
• Creatinine normal OR
• Creatinine clearance ≥ 60 mL/min
• Cardiovascular
• No myocardial infarction within the past 12 months
• No known active ischemic cardiac disease by stress test or echocardiogram
• Gastrointestinal
• No history of gastrointestinal hemorrhage
• No known gastrointestinal ulcers within the past 2 years unless there is documentation of healed lesions by upper endoscopy
• No active or suspected peptic ulcer disease
• Negative stool guaiac test
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study treatment
• No use of snuff or chewing tobacco within the past 2 months
• No active invasive malignancy within the past 3 years except nonmelanoma skin cancer or in situ carcinomas
• No clinical evidence of chronic infectious disease
• No clinical evidence of connective tissue disease
• No known hypersensitivity (asthma, urticaria, or acute rhinitis induced by NSAIDs) to aspirin or other NSAIDs
• No known hypersensitivity to sulfonamides
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• Not specified
• Endocrine therapy
• At least 6 months since prior chronic or frequent use of systemic glucocorticoids
• No concurrent chronic or frequent use of systemic glucocorticoids
• Radiotherapy
• Not specified
• Surgery
• Not specified
• Other
• No prior chronic or frequent (\> 100 mg per day aspirin equivalent) use of nonsteroidal anti-inflammatory drugs (NSAIDs) for 7 of the past 14 days
• At least 3 months since prior experimental therapy
• No concurrent chronic or frequent use of NSAIDs
• * Cardioprotective doses of aspirin ≤ 100 mg daily are allowed