Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease (NCT00084409) | Clinical Trial Compass
CompletedPhase 2
Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
United States152 participantsStarted 2001-11
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Cardia…
What they're measuring
1
Change in Average (Follow-up - Baseline) From All Biopsies