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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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OBJECTIVES:

Primary

* 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 (Antigen Ki-67) in these patients.
* Determine whether this drug affects prostaglandin metabolism in these patients.
* Determine the toxicity profile of this drug in these patients.

Secondary

* Determine whether this drug modulates a panel of biomarkers, including MCM-2(Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth factor receptor: cell surface receptor for the epidermal growth factor family of proteins. Mutations in EGFR expression or activity can result in cancer.) , HER2/neu (Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family), RARβ (Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily), p53, FHIT (Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor), 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.

Conditions

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Lung Cancer Precancerous Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm I

Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.

Group Type EXPERIMENTAL

iloprost

Intervention Type DRUG

Given orally

Arm II

Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

Interventions

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iloprost

Given orally

Intervention Type DRUG

placebo

Given orally

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No