A Phase II Study Of KOS-862 (Epothilone D), Administered Intravenously Weekly For 3 Weeks Every 4 Weeks, In The Second-Line Treatment Of Patients With Advanced Or Metastatic Colorectal Carcinoma (CRC)
- Determine the antitumor activity of epothilone D as second-line treatment, in terms of
objective response rate, in patients with advanced or metastatic refractory colorectal
- Determine the safety of this drug in these patients.
- Determine the response duration in patients responding to treatment with this drug.
- Determine time to tumor progression and overall survival in patients treated with this
- Correlate efficacy and safety with plasma concentrations of this drug and its major
metabolites in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 19-69 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|