A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia
- Compare the clinical efficacy of celecoxib vs placebo, in terms of inducing regression
of oral leukoplakia lesions, in patients with hyperplastic or dysplastic oral
- 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
- Determine the safety of this drug in these patients.
- Determine the cost-effectiveness of this drug as a chemopreventative agent in these
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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Paul F. Engstrom, MD
Fox Chase Cancer Center
United States: Federal Government
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