Pioglitazone to Treat Adults Undergoing Surgery for Non-small Cell Lung Cancer

Stopped early · Phase 2

Conditions studied: Non-Small-Cell Lung Cancer

In brief

Background: * Pioglitazone is a drug that belongs to the class of antidiabetic agents called thiazolidinediones. It is approved for treatment of type 2 diabetes mellitus. * Research suggests that the thiazolidinediones may have anticancer activity that can reduce cancer risk or cause tumors to shrink. Objectives: -To test how a pioglitazone works as a treatment of Stage IA to IIB Non-Small Cell Lung Cancer (NSCLC) and to look at the effect of the drug on cancer cells. Eligibility: -Patients 18 years of age or older who will undergo surgery for Stage IA to IIB non-small cell lung cancer (NSCLC). Design: -The study includes a screening visit to determine eligibility, treatment with pioglitazone, a follow-up visit after 2 to 3 weeks of treatment and a post-surgery visit. Procedures include: 1. Medical history, physical examination, blood tests, electrocardiogram 2. Bronchoscopy to obtain cancer cells. This is done before pioglitazone treatment begins and again during lung surgery. Some patients may also require mediastinoscopy or biopsy to collect cells. 3. Treatment with pioglitazone tablets once a day for at least 2 weeks and no more than 6 weeks, depending on when surgery has been scheduled. 4. Positron emission tomography (PET) scan before starting pioglitazone treatment. National Cancer Institute (NCI) patients also have a follow-up PET scan after treatment but before surgery.

Key facts

Study ID

NCT00923949

Run by

National Cancer Institute (NCI)

People needed

1

Starts

2008-08-01

Expected to finish

2010-03-01

Last updated by the study team

2015-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Pregnant or lactating women.
• Patients who are undergoing chemotherapy, treatment with biologic agents, or radiation therapy. Prior chemotherapy, biologic agent treatment, or radiation therapy, greater than 1 year ago, is allowed.
• Patients with greater than or equal to class II New York Heart Association (NYHA) congestive heart failure or history of congestive heart failure.
• Patients with greater than or equal to grade 2 (moderate) edema.
• Patients with diabetes mellitus being treated with insulin or any pharmacologic therapy.
• Patients taking gemfibrozil or rifampin, due to drug interactions with pioglitazone.
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active liver disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• New York University — New York, New York, United States

Full record on ClinicalTrials.gov

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