Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
Condition: Lung Cancer; Precancerous Condition
MeSH terms: Lung Neoplasms; Precancerous Conditions
Intervention: iloprost; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Iloprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: non-small cell lung cancer; squamous lung dysplasia

Summary:

      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.
    

Eligibility criteria:

        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