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
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Endobronchial Dysplasia
Procedure: fluorescence bronchoscopy
Procedure: quantitative high resolution CT scan
Drug: PIOGLITAZONE VS. PLACEBO 30 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pioglitazone for Lung Cancer Chemoprevention

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Changes in endobronchial histology [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 391
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Current or former smokers receive 6 months of treatment with pioglitazone
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.

Placebo Comparator: Arm 2
Current or former smokers receive 6 months of treatment with placebo
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780234

Contacts
Contact: Mary K Jackson (303) 724-1650 mary.k.jackson@ucdenver.edu
Contact: Brandi Bagwell (303) 724-1654 brandi.bagwell@ucdenver.edu

Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver Recruiting
Denver, Colorado, United States, 80220
Contact: Robert L Keith, MD    303-399-8020 ext 3182    robert.keith@va.gov   
Contact: York E Miller, MD    (303) 393-2869    york.miller@ucdenver.edu   
Principal Investigator: Robert L. Keith, MD         
United States, Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Recruiting
Nashville, Tennessee, United States, 37212-2637
Contact: Rena Burns, RN    615-873-7658    rena.burns@va.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Robert L. Keith, MD VA Eastern Colorado Health Care System, Denver
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00780234     History of Changes
Other Study ID Numbers: CLIN-005-08S
Study First Received: October 24, 2008
Last Updated: June 10, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
chemoprevention
lung cancer
pioglitazone

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014