Clinical trial · Interventional
Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
A Randomized Phase II Chemoprevention Study of Iloprost Versus Placebo in Patients at High Risk for Lung Cancer
NCT00084409CI-TRIAL-00045101completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iloprost | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.
- interventionNames
- Drug: iloprost
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Change in Average (Follow-up - Baseline) From All Biopsies
- timeFrame
- Nine years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTKeith RL, Blatchford PJ, Kittelson J, Minna JD, Kelly K, Massion PP, Franklin WA, Mao J, Wilson DO, Merrick DT, Hirsch FR, Kennedy TC, Bunn PA Jr, Geraci MW, Miller YE. Oral iloprost improves endobronchial dysplasia in former smokers. Cancer Prev Res (Phila). 2011 Jun;4(6):793-802. doi: 10.1158/1940-6207.CAPR-11-0057. PMID 21636546