Pioglitazone for Lung Cancer Chemoprevention

Phase 2

Completed

Interventions: Procedure: fluorescence bronchoscopy
Procedure: quantitative high resolution CT scan
Drug: PIOGLITAZONE VS. PLACEBO 30 mg

Brief Summary: This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial.

Detailed Description: This trial evaluates the oral peroxisome proliferator-activated receptor gamma (PPARgamma) agonist pioglitazone in a double-blind placebo controlled trial. The high risk current and former smokers qualify based on tobacco exposure, airflow limitation on lung function testing, and sputum cytologic atypia. Subjects have a quantitative high resolution thoracic CT scan and a fluorescent bronchoscopy at study entry and after 6 months on drug or placebo. Biologic samples are collected at both time points. The primary outcome is endobronchial histology and determining if pioglitazone can retard progression. Secondary endpoints related to the PPAR gamma signaling pathway will also be analyzed.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

myocardial infarction (MI) with ejection fraction < 50%;
severe/unstable angina;
history of coronary or peripheral arterial bypass grafting;
New York Heart Association (NYHA) class III or IV congestive heart failure;
hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;
life expectancy < 6 months; history of bladder cancer
pregnant or breast feeding; inability to give informed consent

Arm && Interventions

Group	Intervention	Description
Arm 1: pioglitazone	PIOGLITAZONE VS. PLACEBO 30 mg	Current or former smokers receive 6 months of treatment with pioglitazone
Arm 1: pioglitazone	quantitative high resolution CT scan	Current or former smokers receive 6 months of treatment with pioglitazone
Arm 1: pioglitazone	fluorescence bronchoscopy	Current or former smokers receive 6 months of treatment with pioglitazone
Arm 2: placebo	quantitative high resolution CT scan	Current or former smokers receive 6 months of treatment with placebo
Arm 2: placebo	fluorescence bronchoscopy	Current or former smokers receive 6 months of treatment with placebo

Primary Outcome Measures

Name	Time	Method
6-month Histology Score	6 months	Biopsies were classified into one of the following 8 World Health Organization defined categories to classify the endobronchial lesion and assign a score according to the following scale: 1 = normal bronchial epithelium; 2 = reserve cell hyperplasia; 3 = squamous metaplasia without atypia; 4 = mild dysplasia; 5 = moderate dysplasia; 6 = severe dysplasia; 7 = carcinoma in situ (CIS); and 8 = invasive carcinoma. 1 represents the best outcome and 8 represents the worst outcome.

Secondary Outcome Measures

Name	Time	Method

Locations (2): VA Eastern Colorado Health Care System, Denver, CO
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Denver, Colorado, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
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Nashville, Tennessee, United States
VA Eastern Colorado Health Care System, Denver, CO
🇺🇸Denver, Colorado, United States