Status:
COMPLETED
Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Precancerous Condition
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 p...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00101335
Start Date
November 1 2003
End Date
January 1 2005
Last Update
July 11 2013
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497