Lung Cancer Clinical Trial
Official title:
Phase II Study of Imatinib Mesylate and Gemcitabine for Recurrent/Metastatic Non-small Cell Lung Cancer (NSCLC)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor
cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib
mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.
OBJECTIVES:
Primary
- Evaluate the response rate in patients with recurrent or metastatic non-small cell lung
cancer treated with gemcitabine hydrochloride and imatinib mesylate.
Secondary
- Assess time to progression in patients treated with this regimen.
- Assess overall survival and 1-year survival of patients treated with this regimen.
- Assess the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, nonrandomized, uncontrolled, open-label study.
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate
once daily on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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