Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy smokers.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers|
- Modulation of the ki-67 labeling index [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Phenotypic modulation of the bronchial histology [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Evidence of molecular/genetic aberrations [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Changes indicative of response to treatment in the targeted signaling pathway [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2002|
|Study Completion Date:||May 2009|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral placebo twice daily for 6 months.
Experimental: Arm II
Patients receive oral celecoxib twice daily for 6 months.
Given orally. 400mg twice daily for 6 months.
- 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 years.
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 study.
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Jenny T. Mao, MD||Jonsson Comprehensive Cancer Center|