Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00020878|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 4, 2016
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: celecoxib||Phase 2|
- Determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers.
- Determine the safety and long-term side effects of this drug in this population.
OUTLINE: Patients receive oral celecoxib twice daily for 6 months.
Patients are followed at 2 weeks and then at 6 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Celecoxib for Chemoprevention of Primary Lung Cancer|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||November 2002|
|Actual Study Completion Date :||May 2009|
See intervention description.
Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
Other Name: Celebrex
- Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers. [ Time Frame: 1 year ]
- Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2 [ Time Frame: 1 year ]
- Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC [ Time Frame: 2 years ]
- Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment [ Time Frame: 2 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): NCT00020878
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Jenny T. Mao, MD||Jonsson Comprehensive Cancer Center|