RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.
OBJECTIVES: Primary * Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy. Secondary * Determine the safety of this drug in these patients. * Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug. * Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment. * Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients. OUTLINE: This is a multicenter, open-label study. Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 33-85 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
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