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

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

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