Pioglitazone for Lung Cancer Chemoprevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00780234
First received: October 24, 2008
Last updated: June 10, 2014
Last verified: June 2014

October 24, 2008
June 10, 2014
August 2009
December 2014   (final data collection date for primary outcome measure)
Changes in endobronchial histology [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00780234 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pioglitazone for Lung Cancer Chemoprevention
Pioglitazone for Lung Cancer Chemoprevention

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 CAT scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. $150 will be provided to the subject after completing the trial.

This trial evaluates the oral PPAR gamma 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Lung Cancer
  • Endobronchial Dysplasia
  • Procedure: fluorescence bronchoscopy
    examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.
  • Procedure: quantitative high resolution CT scan
    High resolution CT scan of the chest
  • Drug: PIOGLITAZONE VS. PLACEBO 30 mg

    Patients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator-

    activated receptor-gamma agonist. It is FDA approved for the treatment of Type II diabetes. It has been previously administered to non-diabetic subjects. The most common side effect of pioglitazone is fluid retention and modest weight gain. There is a potential risk that pioglitazone may cause an elevation in liver enzymes and more serious hepatotoxicity (rare). There is risk of edema and weight gain associated with pioglitazone therapy. 5% experienced peripheral edema in clinical trials. fluid retention may result in new onset heart failure or exacerbation of existing heart failure. Small risk of hypoglycemia, anemia, myalgia, bone fracture, headache, and macular retinal edema exists. There is insufficient information to confirm its safety in Pregnancy/Breastfeeding. Bladder cancer is more serious but rare.

  • Experimental: Arm 1
    Current or former smokers receive 6 months of treatment with pioglitazone
    Interventions:
    • Procedure: fluorescence bronchoscopy
    • Procedure: quantitative high resolution CT scan
    • Drug: PIOGLITAZONE VS. PLACEBO 30 mg
  • Placebo Comparator: Arm 2
    Current or former smokers receive 6 months of treatment with placebo
    Interventions:
    • Procedure: fluorescence bronchoscopy
    • Procedure: quantitative high resolution CT scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
391
December 2014
December 2014   (final data collection date for primary outcome measure)

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:

  • MI with ejection fraction < 50%;
  • severe/unstable angina;
  • history of coronary or peripheral arterial bypass grafting;
  • 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
Both
18 Years and older
No
Contact: Mary K Jackson (303) 724-1650 mary.k.jackson@ucdenver.edu
Contact: Brandi Bagwell (303) 724-1654 brandi.bagwell@ucdenver.edu
United States
 
NCT00780234
CLIN-005-08S
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Robert L. Keith, MD VA Eastern Colorado Health Care System, Denver
Department of Veterans Affairs
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP