Pioglitazone to Treat Adults Undergoing Surgery for Non-small Cell Lung Cancer
Status:
Terminated
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
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.