Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
- Compare the rate of new malignancies (recurrences and second primary tumors) in
patients with early-stage head and neck cancer or non-small cell lung cancer treated
with celecoxib vs placebo.
- Compare the event-free and overall survival of patients treated with this drug vs
- Determine the toxic effects associated with long-term use of celecoxib in these
- Correlate cyclooxygenase-2 and transforming growth factor (TGF)-beta expression and
CYP2C9 and TGF-beta genotypes with the rate of new malignancies and survival of
patients treated with this drug vs placebo.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients
are stratified according to smoking history (active smokers [including those who quit within
1 year of diagnosis] vs former smokers vs non-smokers), tumor type (lung cancer vs head and
neck cancer), and stage (I vs II for head and neck cancer or T1 vs T2 for lung cancer).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues
for 24 months in the absence of disease recurrence or unacceptable toxicity.
Patients are followed every 6 months for 5 years or until disease recurrence.
PROJECTED ACCRUAL: A total of 121 patients (approximately 60 per treatment arm) will be
accrued for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Athanassios Argiris, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Rush Cancer Institute at Rush University Medical Center||Chicago, Illinois 60612|