Phase II Double-Blind, Placebo Controlled, Randomized Study Of Celecoxib, A Selective COX-2 Inhibitor, In Oral Premalignant Lesions
OBJECTIVES: I. Determine the efficacy of celecoxib, in terms of clinical response and
histological response, in patients with oral premalignant lesions. II. Evaluate the safety
of chronic multiple dosing of celecoxib in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to premalignant risk (early vs advanced). Patients in each stratum
are randomized to 1 of 3 treatments arms. Arm I: Patients receive lower-dose oral celecoxib
twice daily. Arm II: Patients receive higher-dose oral celecoxib twice daily. Arm III:
Patients receive oral placebo twice daily. Treatment continues in all 3 arms for 12 weeks in
the absence of disease progression or unacceptable toxicity. Patients are followed at 18,
24, and 26 weeks.
PROJECTED ACCRUAL: A total of 84 patients (42 per stratum, 14 per arm) will be accrued for
this study within 6 months.
Primary Purpose: Prevention
Jay O. Boyle, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Weill Medical College of Cornell University||New York, New York 10021|