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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00751725 |
RATIONALE: Pioglitazone may help lung cancer cells become more like normal cells, and grow and spread more slowly.
PURPOSE: This phase II trial is studying how well pioglitazone works in treating patients with newly diagnosed stage I or stage II non-small cell lung cancer who are undergoing surgery.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: pioglitazone hydrochloride Procedure: TdT-mediated dUTP nick end labeling assay Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: therapeutic conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Pilot Trial of Pioglitazone in Adults Undergoing Surgical Resection of Non-Small Cell Lung Cancer |
Estimated Enrollment: | 25 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral pioglitazone hydrochloride once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo definitive surgical resection.
Patients undergo blood and tissue sample collection periodically for biomarker correlative studies. Tissue biomarkers (i.e., apoptotic index, Ki-67, cyclin D1, p21/Waf1, PPARγ, MUC1, gelsolin, proline oxidase, and 15-hydroxyprostaglandin dehydrogenase) are assessed by TUNEL and IHC. Serum markers (i.e., C-reactive protein, CA 15-3, CEA, and CA-125) are also assessed.
Some patients undergo a FDG-PET scan at baseline and after ≥ 2 weeks of treatment with pioglitazone hydrochloride to assess tumor metabolic activity.
Patients are followed at 4-6 weeks after surgery.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, New York | |
NYU Cancer Institute at New York University Medical Center | Recruiting |
New York, New York, United States, 10016 | |
Contact: Marc Ballas, MD 212-731-6645 |
Principal Investigator: | Giuseppe Giaccone, MD, PhD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000614259, NCI-08-C-0208 |
Study First Received: | September 11, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751725 |
Health Authority: | Unspecified |
stage I non-small cell lung cancer stage II non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Pioglitazone Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Hypoglycemic Agents Neoplasms by Site |
Neoplasms by Histologic Type Physiological Effects of Drugs Pharmacologic Actions |