Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
Lung Cancer
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring non-small cell lung cancer, stage I non-small cell lung cancer
Eligibility Criteria
Inclusion Criteria: Heavy former smokers without prior history of NSCLC Age > 45 Smoked for minimum of 30 pack years Former smokers with prior curative resection of surgical stage I NSCLC will be recruited and must be: Age > 18 Smoked > 10 pack years Must have had pathological staging and the extent of disease documented. At least one nodal station each must have been biopsied and all biopsies must have been negative At least 6 months post curative resection of Stage I prior NSCLC, without evidence for recurrence or second primary lung cancer Normal blood chemistry and cell counts Negative pregnancy test Exclusion Criteria: Framingham 10-year-risk for coronary artery disease score > 10% History of cardiovascular disease Evidence of diffuse coronary calcification on screening CT Concurrent use of NSAIDs. The use of cardiac (baby) Aspirin is permitted Hypersensitivity to celecoxib, sulfonamides, aspirin or other NSAIDs Liver dysfunction [abnormally elevated liver function tests [transaminases (ALT, AST) > ULN, alkaline phosphatase (ALKP) > 1.5 ULN]] or history of cirrhosis No peptic ulcer disease (PUD) diagnosis nor active symptoms in the last 2 years or, if PUD was diagnosed < 2 years, there must be no active symptoms, and endoscopic confirmation of healing Renal dysfunction [abnormally elevated blood urea nitrogen (BUN) > 1.5 ULN and creatinine > ULN] End state respiratory disease Unstable angina or a history of significant coronary artery disease Other malignancies excluding non-melanoma type skin cancer and in situ cervical cancer. Persons with stage I/II head and neck cancer must be disease free for at least 12 months Pregnancy Lactation Unwillingness to practice contraception On systemic corticoid steroid therapy Coagulopathy Use of Coumadin Concurrent use of medication know to alter or be affected by alteration of hepatic p450 2C9 enzymes. Patients with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule Patients who had received photosensitizing agents such as hematoporphyrin derivative or chemopreventive drugs such as retinoids within 3 months prior to the bronchoscopic procedure, radiotherapy to the chest, or cytotoxic chemotherapy agents Subject found to have CIS during screening bronchoscopy will be treated with local therapy prior to randomization
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients receive oral placebo twice daily for 6 months.
Patients receive oral celecoxib twice daily for 6 months.