Lung Cancer
Pilot Trial of Pioglitazone in Patients Undergoing Surgical Resection of Non-Small Cell Lung Cancer
NCI-08-C-0208
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Investigator(s): |
Giuseppe Giaccone, M.D., Ph.D.
Principal Investigator
Phone: 301-496-4916
Fax: 301-402-0172
giacconeg@mail.nih.gov
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Arlene Berman, R.N., M.S., O.C.N.
Research Nurse
Phone: 301-435-5609
arleneb@mail.nih.gov
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Laura D. Otten, R.N., B.S.N., O.C.N.
Medical Oncology Referral Coordinator
Phone: 301-451-1228
1-866-611-6310 (Toll Free)
Fax: 301-480-0919
ottenl@mail.nih.gov
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Primary Eligibility:
- Histologically confirmed non-small cell lung cancer
- Newly diagnosed disease
- Resectable stage IA-IIB disease
- Scheduled to undergo definitive surgery
- No prior radiotherapy to the chest
- No concurrent insulin or pharmacologic therapy for treatment of diabetes mellitus
- No concurrent gemfibrozil or rifampin
- Recovered from all prior therapy
- ECOG 0-2
- ANC ≥ 1,500/mL
- Hemoglobin > 10 g/dL
- Platelet count ≥ 100,000/mL
- Billirubin < 1.8 mg/dL
- AST and ALT < 1.5 x upper limit of normal (ULN)
- Creatinine < 1.5 x ULN
- Not pregnant or nursing; fertile patients must use effective non-hormonal contraception
- Willing to swallow oral study tablets
- Willing to undergo two bronchoscopies during study participation
- No NYHA class II-IV congestive heart failure or history of congestive heart failure
- No edema ≥ grade 2
- No medical condition that would preclude study participation
Treatment Plan:
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 periodic blood and tissue sample collection
- Patients undergo a FDG-PET scan at baseline
- Patients at the National Cancer Institute also receive a FDG-PET scan after ≥ 2 weeks of treatment with pioglitazone hydrochloride
- Patients are followed 4-6 weeks after surgery
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 10/24/08
Updated: 10/24/08
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