Lung Cancer Clinical Trial
Official title:
A Phase II Study of Docetaxel and Vinorelbine in Advanced Non-Small Cell Lung Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
Colony-stimulating factors such as filgrastim may increase the number of immune cells found
in bone marrow or peripheral blood and may help a person's immune system recover from the
side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
filgrastim in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES: I. Determine the response to docetaxel and vinorelbine with filgrastim (G-CSF)
support in patients with stage IIIB or IV non-small cell lung cancer. II. Determine the
toxicity of this regimen in these patients. III. Determine the overall survival and time to
tumor progression in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes and
docetaxel IV over 1 hour on day 1 and filgrastim (G-CSF) subcutaneously daily on days 2-12
or until blood counts recover. Treatment continues every 2 weeks in the absence of disease
progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.
;
Primary Purpose: Treatment
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