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Phase 2 trial of epothilone B analog BMS-247550 (ixabepilone) in advanced carcinoma of the urothelium (E3800)†
A trial of the eastern cooperative oncology group
Article first published online: 26 JUN 2007
Copyright © 2007 American Cancer Society
Volume 110, Issue 4, pages 759–763, 15 August 2007
How to Cite
Dreicer, R., Li, S., Manola, J., Haas, N. B., Roth, B. J. and Wilding, G. (2007), Phase 2 trial of epothilone B analog BMS-247550 (ixabepilone) in advanced carcinoma of the urothelium (E3800). Cancer, 110: 759–763. doi: 10.1002/cncr.22839
This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD) and supported in part by Public Health Service grants CA23318, CA66636, CA21115, CA27525, CA49957, CA21076 and the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
- Issue published online: 2 AUG 2007
- Article first published online: 26 JUN 2007
- Manuscript Accepted: 26 MAR 2007
- Manuscript Revised: 23 MAR 2007
- Manuscript Received: 5 FEB 2007
- phase 2 trial;
- urothelial carcinoma
Paclitaxel and docetaxel are active agents in advanced urothelial cancer. BMS-247550 (ixabepilone) has activity in preclinical models in paclitaxel resistant models. A phase 2 trial of this epothilone was performed to determine the activity and toxicity of this agent in a multi-institutional setting in patients previously treated with 1 prior chemotherapy regimen.
Forty-five patients with advanced urothelial carcinoma were treated with BMS-247550 40 mg/m2 over 3 hours intravenously on Day 1 of a 21-day cycle and continued therapy until progression or unacceptable toxicity.
Five patients obtained an objective partial response (PR) among the 42 eligible patients for an overall response rate of 11.9% (90% confidence interval [5.3%, 26.5%]). Median overall survival of the group was 8 months. Toxicity was moderate with granulocytopenia, fatigue, and sensory neuropathy being the most common side effects noted.
BMS-247550 (ixabepilone) has very modest activity as a second-line therapy for advanced urothelial cancer. Responses in visceral, nodal, and soft tissues sites were observed. Granulocytopenia without fever, fatigue, and sensory neuropathy was common. Cancer 2007. © 2007 American Cancer Society.