Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Cancer Institute (NCI)
• Treatments: Iloprost

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