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

2014-07-24 14:33:18 | BioPortfolio


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.




- 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 sputum atypia) treated with iloprost vs placebo.

- Determine whether this drug modulates Ki-67 proliferation index in these patients.

- Determine whether this drug affects prostaglandin metabolism in these patients.

- Determine the toxicity profile of this drug in these patients.


- Determine whether this drug modulates a panel of biomarkers, including MCM-2, EGFR, HER2/neu, RARβ, p53, FHIT, apoptotic index, and microvessel density, in these patients.

- Determine the genes whose expression is altered by this drug in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to smoking status (current vs former) and participating center. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral iloprost twice daily.

- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity.

Patients are followed at 1 month and then annually thereafter.

PROJECTED ACCRUAL: A total of 152 patients (76 [38 current smokers and 38 former smokers] per treatment arm) will be accrued for this study within 2 years.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Prevention


Lung Cancer


iloprost, placebo


University of Colorado Cancer Center at UC Health Sciences Center
United States




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-07-24T14:33:18-0400

Clinical Trials [3376 Associated Clinical Trials listed on BioPortfolio]

Effect of Iloprost on Pulmonary Oxygenation in Patients With Low Diffusing Capacity During One-lung Ventilation

One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far, hyp...

Effects of Iloprost on Pulmonary Hemodynamics and Oxygenation in Patients of Chronic Obstructive Pulmonary Disease During One-lung Ventilation

The inhaled Iloprost, approved for pulmonary hypertension, caused increase in oxygenation, and increase exercise tolerance in ARDS or chronic obstructive pulmonary disease. Inhaled ilopros...

Iloprost-Study: Comparison of Nitric Oxide to Iloprost (Ventavis) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery

Inhaled nitrous oxide (iNO) will be compared to aerosolized iloprost (ILO) in pediatric patients after cardiac surgery with pulmonary hypertension. The hypothesis is that iloprost is more ...

Iloprost in High Risk Cardiac Surgical Patients

In this study effects of the intra operative, prophylactic inhalation of Iloprost (Ventavis) before and during extracorporal circulation on perioperative morbidity and outcome in high risk...

Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)

The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Ilopro...

PubMed Articles [16276 Associated PubMed Articles listed on BioPortfolio]

Daily Lisinopril vs Placebo for Prevention of Chemoradiation-Induced Pulmonary Distress in Patients With Lung Cancer (Alliance MC1221): A Pilot Double-Blind Randomized Trial.

Chemoradiation (CRT) is an integral treatment modality for patients with locally advanced lung cancer. It has been hypothesized that current use of an angiotensin-converting enzyme inhibitor during CR...

Cost-utility analysis of a potential lung cancer screening program for a high-risk population in Germany: A modelling approach.

Lung cancer is the leading cause of cancer death in Germany. Although several randomized trials in Europe have evaluated the effectiveness of lung cancer screening programs, evidence on the cost-effec...

Lung Cancer Among Women in the United States.

November marks Lung Cancer Awareness Month, and reminds us that lung cancer is the leading cause of cancer death among women in the United States. In this brief report, we highlight CDC resources that...

Lung Cancer: One Disease or Many.

Lung cancer is classified as a single entity comprised of multiple histological subtypes. But how similar are these subtypes on a genetic level? This paper aims to address this question through a conc...

An Update on the European Lung Cancer Screening Trials and Comparison of Lung Cancer Screening Recommendations in Europe.

While lung cancer screening has been implemented in the United States, it is still under consideration in Europe. So far, lung cancer screening trials in Europe were not able to replicate the results ...

Medical and Biotech [MESH] Definitions

An eicosanoid, derived from the cyclooxygenase pathway of arachidonic acid metabolism. It is a stable and synthetic analog of EPOPROSTENOL, but with a longer half-life than the parent compound. Its actions are similar to prostacyclin. Iloprost produces vasodilation and inhibits platelet aggregation.

Tumors or cancer of the LUNG.

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

More From BioPortfolio on "Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease"

Quick Search


Relevant Topics

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

Lung Cancer
Lung cancer is the uncontrolled cell growth in tissues of the lung. Originating in the lungs, this growth may invade adjacent tissues and infiltrate beyond the lungs. Lung cancer, the most common cause of cancer-related death in men and women, is respons...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Searches Linking to this Trial