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

Fox Chase Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Head and Neck Cancer Precancerous Condition

Interventions

celecoxibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Data from ClinicalTrials.gov

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