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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer. PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this disease. OBJECTIVES: Primary * Compare the reversal of premalignant histological changes in the bronchial epithelium of patients at high risk for lung cancer (defined by > 20 pack years of smoking and sputum atypia) treated with iloprost vs placebo. * Determine whether this drug modulates Ki-67 proliferation index (Antigen Ki-67) in these patients. * Determine whether this drug affects prostaglandin metabolism in these patients. * Determine the toxicity profile of this drug in these patients. Secondary * Determine whether this drug modulates a panel of biomarkers, including MCM-2(Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth factor receptor: cell surface receptor for the epidermal growth factor family of proteins. Mutations in EGFR expression or activity can result in cancer.) , HER2/neu (Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family), RARβ (Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily), p53, FHIT (Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor), apoptotic index, and microvessel density, in these patients. * Determine the genes whose expression is altered by this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to smoking status (current vs former) and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral iloprost twice daily. * Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity. Patients are followed at 1 month and then annually thereafter. PROJECTED ACCRUAL: A total of 152 patients (76 \[38 current smokers and 38 former smokers\] per treatment arm) will be accrued for this study within 2 years.
Inclusion Criteria: * Current or former smoker with ≥ 20 pack-year history of smoking with no tobacco use within the past 6 months * Mild atypia or worse on sputum cytology, or * Bronchial biopsy with mild or worse dysplasia within the past 12 months * Age 18 and over * SWOG (Southwest Oncology Group)0-2 * Life expectancy at least 6 months * Granulocyte count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN) * Transaminases ≤ 2.5 times ULN * Bilirubin ≤ 2.0 mg/dL * Albumin ≥ 2.5 g/dL * Creatinine ≤ 1.5 mg/dL * Well-controlled atrial fibrillation OR rare (\< 2 minutes) premature ventricular contractions allowed * Negative pregnancy test * Fertile patients must use effective contraception * Able and willing to undergo bronchoscopy Exclusion Criteria * Clinically apparent bleeding diathesis * Ventricular tachycardia * Multifocal premature ventricular contractions or supraventricular tachycardias with rapid ventricular response * Pneumonia or acute bronchitis within the past 2 weeks * Hypoxemia (\< 90% saturation with supplemental oxygen) * Pregnant or nursing * Malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Serious medical condition that would preclude bronchoscopy or study participation * Clinically active coronary artery disease * Myocardial infarction within the past 6 weeks * Chest pain * Congestive heart failure * Cardiac dysrhythmia that is potentially life-threatening Exclusion for PRIOR CONCURRENT THERAPY: * Biologic therapy (Not specified) * More than 5 years since prior chemotherapy * More than 6 weeks since prior inhaled steroids * More than 5 years since prior thoracic radiotherapy * Surgery (Not specified) * No prior prostacyclin
are designated in this study
of being blinded to the placebo group