A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia
18 Years
N/A
Both
Head and Neck Cancer, Precancerous Condition
Trial Information
A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Principal Investigator
Paul F. Engstrom, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000393574
NCT ID:
NCT00101335
Start Date:
September 2004
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Precancerous Condition
- hypopharyngeal cancer
- lip and oral cavity cancer
- nasopharyngeal cancer
- oropharyngeal cancer
- tongue cancer
- oral leukoplakia
- Head and Neck Neoplasms
- Leukoplakia
- Leukoplakia, Oral
- Precancerous Conditions
Name | Location |
|---|---|
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
