Head and Neck Cancer Clinical Trial
Official title:
Phase II Double-Blind, Placebo Controlled, Randomized Study Of Celecoxib, A Selective COX-2 Inhibitor, In Oral Premalignant Lesions
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development of cancer. The use of celecoxib may be an effective way to prevent the further
development of precancerous lesions in the mouth.
PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of
celecoxib in treating patients who have precancerous lesions in the mouth.
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
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