Lung Cancer
Conditions
Keywords
non-small cell lung cancer
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.
Interventions
DRUGcelecoxib
Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 45 * Smoked \> 20 pack years
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers. | 1 year |
| Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2 | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed