Pioglitazone to Treat Adults Undergoing Surgery for Non-small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00923949|
Recruitment Status : Terminated (Study never published; terminated early due to low accrual.)
First Posted : June 18, 2009
Results First Posted : February 14, 2012
Last Update Posted : September 30, 2015
- 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.
-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.
-Patients 18 years of age or older who will undergo surgery for Stage IA to IIB non-small cell lung cancer (NSCLC).
-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:
- Medical history, physical examination, blood tests, electrocardiogram
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Cancer||Drug: Pioglitazone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial of Pioglitazone in Adults Undergoing Surgical Resection of Non-Small Cell Lung Cancer|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
45 mg tablet daily by mouth for six weeks
45 mg tablet daily by mouth for six weeks
- Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue [ Time Frame: 58 days ]Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.
- Number of Participants With Effects of Pioglitazone on Multiple Biomarkers in Tumor [ Time Frame: 58 days ]Apoptotic index (A1) will be assessed by terminal deoxynucleotidyl transferase dUTP end labeling (TUNEL) and cyclin D1, p21/Waf1, PPARy, MUC1, gelsolin, proline oxidase, and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) will be assessed by immunohistochemistry.
- Number of Participants With Adverse Events [ Time Frame: 58 days ]Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.
- Number of Participants With Metabolic Activity Determined by Fludeoxyglucose Positron-emission Tomography (FDG-PET) [ Time Frame: 58 days ]Response will be evaluated by FDG-PET. Response is defined as a decrease of standardized uptake values (SUV) of more than one.
- Number of Participants With Effects of Pioglitazone on Premalignant Tissue Biomarkers [ Time Frame: 58 days ]Premalignant tissue biomarkers ki-67, apoptotic index and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.
- Number of Participants With Effects of Pioglitazone on Histologically Normal Tissue Biomarkers [ Time Frame: 58 days ]ki-67 and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.
- Number of Participants With Effects of Pioglitazone on Serum Tumor Markers [ Time Frame: 58 days ]C-reactive protein, cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA-125) and carcinoembryonic antigen (CEA) will be assessed by immunohistochemistry.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923949
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, New York|
|New York University|
|New York, New York, United States, 10016|
|Principal Investigator:||Giuseppe Giaccone, M.D.||National Cancer Institute (NCI)|