Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
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|ClinicalTrials.gov Identifier: NCT00055978|
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : June 20, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: celecoxib Other: placebo||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers|
|Study Start Date :||October 2002|
|Primary Completion Date :||March 2008|
|Study Completion Date :||May 2009|
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.
- Modulation of the ki-67 labeling index [ Time Frame: 5 years ]
- Phenotypic modulation of the bronchial histology [ Time Frame: 5 years ]
- Evidence of molecular/genetic aberrations [ Time Frame: 5 years ]
- Changes indicative of response to treatment in the targeted signaling pathway [ Time Frame: 5 years ]
- Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055978
|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|