Pioglitazone for Lung Cancer Chemoprevention
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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 |
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00780234
| Contact: Mary K Jackson | (303) 724-1650 | mary.k.jackson@ucdenver.edu | |
| Contact: Brandi Bagwell | (303) 724-1654 | brandi.bagwell@ucdenver.edu |
| 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 | |
| Principal Investigator: | Robert L. Keith, MD | VA Eastern Colorado Health Care System, Denver |
More Information
Additional 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: | November 18, 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:
|
Pioglitazone Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015