Pioglitazone for Lung Cancer Chemoprevention

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: Endobronchial Dysplasia; Lung Cancer

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00780234

CLIN-005-08S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current or former smoker (at least 10 pack years);
• One or more of the following:
• Mild or worse sputum atypia
• Airflow Limitation (FEV1/FVC<70% predicted)
• Biopsy proven airway dysplasia

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups, including a placebo group

Arm 1: pioglitazone

Experimental group

Description:

Current or former smokers receive 6 months of treatment with pioglitazone

Treatment:

Procedure: quantitative high resolution CT scan

Procedure: fluorescence bronchoscopy

Drug: PIOGLITAZONE VS. PLACEBO 30 mg

Arm 2: placebo

Placebo Comparator group

Description:

Current or former smokers receive 6 months of treatment with placebo

Treatment:

Procedure: quantitative high resolution CT scan

Procedure: fluorescence bronchoscopy