Lung Cancer Clinical Trial
Official title:
Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of celecoxib may be an effective way to prevent
the recurrence of stage I or stage II head and neck cancer or stage I non-small cell lung
cancer.
PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works
compared to that of a placebo in preventing disease recurrence in patients with stage I or
stage II head and neck cancer or stage I non-small cell lung cancer.
OBJECTIVES:
- 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
placebo.
- Determine the toxic effects associated with long-term use of celecoxib in these
patients.
- 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
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