A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
Naiyer Rizvi, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|