Pioglitazone for Lung Cancer Chemoprevention
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | June 2016 |
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.
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.
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.
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.
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
We found this trial at
2
sites
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