Lung Cancer Clinical Trial
Official title:
A Phase II Study of Oxaliplatin in Combination With Paclitaxel in 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and oxaliplatin
in treating patients who have recurrent or advanced non-small cell lung cancer.
OBJECTIVES: I. Determine the overall, partial, and complete response rates in patients with
advanced non-small cell lung cancer treated with oxaliplatin plus paclitaxel. II. Assess the
overall survival, time to tumor progression, and toxicities associated with this combination
regimen in this patient population. III. Assess the neurologic toxicity of this combination
regimen and its correlation with creatinine clearance in these patients.
OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour followed by
oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of
disease progression or unacceptable toxicity. Patients are followed for at least 2 years or
until death.
PROJECTED ACCRUAL: Approximately 17-37 patients will be accrued for this study within 24
months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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