Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Study of Intermittent Gleevec® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-Small Cell Lung Cancer
This phase II trial is studying how well giving imatinib mesylate together with paclitaxel works in treating older patients with stage IIIB or stage IV non-small cell lung cancer. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with paclitaxel may kill more tumor cells
PRIMARY OBJECTIVES:
I. To estimate the clinical efficacy of the combination of weekly paclitaxel and
intermittent imatinib in elderly patients with advanced non-small cell lung cancer.
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of the combination of weekly paclitaxel and intermittent
imatinib in elderly patients with advanced non-small cell lung cancer.
II. To collect paraffin tissue blocks for a companion project evaluating the expression of
platelet derived growth factor (PDGF) by original tumor specimens, and its relationship to
response rate and survival.
OUTLINE:
Patients receive paclitaxel intravenously (IV) on days 3, 10, and 17 and imatinib mesylate
orally (PO) once daily (QD) on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days
for 4-6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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