Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Head and Neck Cancer, Precancerous Condition
About this trial
This is an interventional prevention trial for Head and Neck Cancer focused on measuring hypopharyngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, tongue cancer, oral leukoplakia
Eligibility Criteria
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
Sites / Locations
- Fox Chase Cancer Center