Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Precancerous Condition, Stage I Non-small Cell Lung Cancer, Tobacco Use Disorder
About this trial
This is an interventional prevention trial for Precancerous Condition
Eligibility Criteria
Inclusion Criteria: Current or former smoker who has smoked at least 30 pack years AND meets 1 of the following criteria: No prior lung cancer Prior stage I non-small cell lung cancer(NSCLC) that was completely resected ≥ 1 year ago OR for which patient completed adjuvant chemotherapy ≥ 1 year ago Tissue blocks, blood, and sputum samples available for research purposes No carcinoma in situ ECOG performance status 0-1 Hemoglobin ≥ 12.0 g/dL (women) or hemoglobin ≥ 13.5 g/dL (men) WBC ≥ 3,000/mm³ Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT ≤ 1.5 times ULN Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥30 mL/min Room air oxygen saturation ≥ 90% Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Negative chest x-ray Negative electrocardiogram No other cancer within the past 3 years except nonmelanoma skin cancer, localized prostate, carcinoma in situ of the cervix cancer, or superficial bladder cancer Treatment must have been completed > 6 months ago No prior gastrointestinal ulceration, bleeding, or perforation No uncontrolled illness including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Myocardial infarction within the past 6 months Chronic renal disease Chronic liver disease Difficult to control hypertension Psychiatric illness or social situations that would limit study compliance No known HIV positivity No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria No known sensitivity to yellow dye FD&C Yellow #5 No continuous or intermittent supplemental oxygen At least 6 months since prior participation in another chemoprevention trial At least 6 months since prior regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (may be eligible after washout period of 12 weeks for NSAIDs and 6 weeks for corticosteroids) No prior pneumonectomy No prior solid organ transplantation No other concurrent investigational agents No concurrent regular use of acetylsalicylic acid (aspirin) unless prescribed by a physician for prevention Maximum of 1 aspirin (81 mg) per day allowed No concurrent use of any of the following: Methotrexate Corticosteroids Antiplatelet agents: Warfarin Ticlopidine Clopidogrel bisulfate Aspirin Abciximab Dipyridamole Eptifibatide Tirofiban hydrochloride Lithium carbonate Cyclosporine Hydralazine Angiotensin-converting enzyme (ACE) inhibitors (ACE receptor antagonists are allowed) Angiotensin receptor blockers
Sites / Locations
- Mayo Clinic in Arizona
- H. Lee Moffitt Cancer Center and Research Institute
- Lahey Hospital and Medical Center
- Mayo Clinic
- Cleveland Clinic Foundation
- British Columbia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I
Arm II
Patients receive oral sulindac twice daily for 6 months.
Patients receive oral placebo twice daily for 6 months.