Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Lung Cancer, Precancerous Condition
In brief
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.
Key facts
- Study ID
- NCT00084409
- Run by
- University of Colorado, Denver
- People needed
- 152
- Starts
- 2001-11-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2020-05-14
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Colorado Cancer Center at UC Health Sciences Center — Aurora, Colorado, United States
- Veterans Affairs Medical Center - Denver — Denver, Colorado, United States
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
- Mayo Clinic Cancer Center — Rochester, Minnesota, United States
- UPMC Cancer Centers — Pittsburgh, Pennsylvania, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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