Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers
- Determine the feasibility of chemoprevention of lung cancer with celecoxib in former
heavy smokers at risk for developing primary or second primary lung cancer.
- Determine the safety and side effects of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
- Determine the role of COX-2-specific inhibitors (e.g., celecoxib) on antitumor immunity
within the lung microenvironment of these patients.
- Determine the effects of COX-2 inhibition on angiogenesis in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to presence of preinvasive lesions (yes vs no). Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo twice daily for 6 months.
- Arm II: Patients receive oral celecoxib twice daily for 6 months. Treatment in both
arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed every 6 months during treatment and then annually for up to 4
Patients are followed annually for up to 4 years.
PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Modulation of the ki-67 labeling index
Jenny T. Mao, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|