Lung Cancer Clinical Trial
Official title:
A Research Study Evaluating Oral and Intravenous NAVELBINE as a Single Agent for the Treatment of Chemotherapy-Naive Subjects With Inoperable Stage IIIb or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving drugs in different ways may kill more tumor cells. It is
not yet known whether giving vinorelbine by mouth or infusion is more effective in treating
non- small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of vinorelbine given by
mouth or as an infusion in treating patients who have stage IIIB or stage IV non-small cell
lung cancer.
OBJECTIVES: I. Compare the safety and efficacy of oral versus intravenous vinorelbine in
patients with stage IIIB or IV non-small cell lung cancer. II. Compare the quality of life
of patients treated with these regimens. III. Compare the pharmacokinetics of these
treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive oral vinorelbine weekly. Arm II: Patients receive
vinorelbine IV over 10 minutes weekly. Treatment continues in the absence of disease
progression or unacceptable toxicity. Quality of life is assessed several times during
treatment and 4 weeks after treatment. Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A maximum of 195 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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