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

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of celecoxib may prevent or treat head and neck cancer. PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to placebo in preventing head and neck cancer in patients with oral leukoplakia.

Detailed Description
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OBJECTIVES: Primary Compare the clinical efficacy of celecoxib vs placebo, in terms of inducing regression of oral leukoplakia lesions, in patients with hyperplastic or dysplastic oral leukoplakia. Secondary Determine the effect of this drug in modulating multiple intermediate biomarkers (e.g., COX-2, PPARγ, or PPARδ) in normal and hyperplastic or dysplastic oral epithelia of these patients. Determine the safety of this drug in these patients. Determine the cost-effectiveness of this drug as a chemopreventative agent in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, cross-over study. Patients are stratified according to the pathology of the leukoplakia lesion (dysplasia vs hyperplasia). Patients are randomized to 1 of 2 arms. Arm I: Patients receive oral celecoxib twice daily for 3 months. Arm II: Patients receive oral placebo twice daily for 3 months. All patients undergo biopsy. Patients then cross-over to the opposite treatment arm for 3 months. In both arms, treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 27-60 patients (18-40 for study drug, 9-20 for placebo before cross-over) will be accrued for this study.

Official Title
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A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia

Conditions
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Head and Neck Cancer, Precancerous Condition

Intervention / Treatment
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* Drug: celecoxib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypopharyngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, tongue cancer, oral leukoplakia