Phase 2 N=152 Randomized Triple-blind Prevention

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

Lung Cancer · Precancerous Condition

Bottom Line

View on ClinicalTrials.gov: NCT00084409 ↗

Enrolled (actual)

152

Serious AEs

5.9%

Results posted

Feb 2013

Primary outcome: Primary: Change in Average (Follow-up - Baseline) From All Biopsies — -0.23; -0.02 WHO Units

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: iloprost (Drug); placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Average (Follow-up - Baseline) From All Biopsies	-0.23; -0.02	—
SECONDARY Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies	-7.70; -0.92	—
SECONDARY Change in Average (Follow-up - Baseline) Using Reference Sites	-0.23; -0.01	—
SECONDARY Change in Maximum (Follow-up - Baseline) Using Reference Sites	-0.35; 0.11	—
SECONDARY Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites	-7.61; 0.15	—
SECONDARY Change in Average (Follow-up - Baseline) Using Matched Sites	-0.24; -0.06	—
SECONDARY Change in Maximum (Follow-up - Baseline) Using Matched Sites	-0.53; 0.11	—
SECONDARY Change in Dysplasia Index (Follow-up - Baseline) Using Matched Sites	-7.97; -2.34	—
SECONDARY Change in Average (Follow-up - Baseline) Using Baseline Non-Normal Pairs	-0.71; -0.38	—
SECONDARY Change in Maximum (Follow-up - Baseline) Using Baseline Non-Normal Pairs	-0.81; -0.13	—
SECONDARY Change in Dysplasia Index (Follow-up - Baseline) Using Baseline Non-Normal Pairs	-14.32; -6.48	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00084409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.