Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
- Registration Number
- NCT00020878
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Age > 45
- Smoked > 20 pack years
- Concurrent use of NSAIDs
- Hypersensitivity to celecoxib
- Documented allergic-type reaction to sulfonamides
- History of allergic reaction, urticaria or asthma to aspirin or other NSAIDs
- History of liver dysfunction
- Hypertension or cardiac conditions aggravated by fluid retention and edema
- Previous history of gastrointestinal ulceration, bleeding, or perforation
- Renal dysfunction
- End stage respiratory disease
- Unstable angina
- Other malignancy
- Pregnancy
- Concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2C9 and 2D6 enzymes
- Patents with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study celecoxib See intervention description.
- Primary Outcome Measures
Name Time Method Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2 1 year Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers. 1 year
- Secondary Outcome Measures
Name Time Method Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC 2 years Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment 2 years
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States