Status:
COMPLETED
Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Precancerous Condition
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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...
Detailed Description
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 sputu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00084409
Start Date
November 1 2001
End Date
January 1 2009
Last Update
May 14 2020
Active Locations (6)
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1
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
2
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
3
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
4
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905