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Investigational New Drugs
Published in: Investigational New Drugs 6/2010

01-12-2010 | PHASE II STUDIES

The epothilone B analogue ixabepilone in patients with advanced hepatobiliary cancers: a trial of the University of Chicago Phase II Consortium

Authors: Halla S. Nimeiri, Deepti A. Singh, Kristen Kasza, David A. Taber, Rafat H. Ansari, Everett E. Vokes, Hedy L. Kindler

Published in: Investigational New Drugs | Issue 6/2010

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Summary

Purpose Hepatobiliary cancers respond poorly to cytotoxic chemotherapy. We evaluated the activity and safety of ixabepilone, an epothilone B analogue which stabilizes microtubules, in a phase II trial in patients with advanced cancers of the gallbladder, bile duct, and liver. Methods Eligible patients had previously-untreated, histologically-proven unresectable hepatobiliary cancer. Ixabepilone, 40 mg/m2, was administered intravenously over 3 h every 21 days. Results Between January 2002 and April 2005, 54 patients (19 hepatocelluar carcinoma, 13 cholangiocarcinomas, 22 gallbladder carcinomas) were enrolled; 47 patients were evaluable for efficacy. The objective response rate was 8.5%; 51% had stable disease. Median overall survival was 7.0 months (95% CI, 5.0 to 10.8 months) and median progression-free survival was 2.6 months (95% CI, 1.4 to 4.1 months). Grade 3/4 toxicities included neutropenia (39%), fatigue (9%), allergic/hypersensitivity reaction (4%) and sensory neuropathy (4%). Conclusion Single agent ixabepilone has limited activity in advanced hepatobiliary cancers.
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Metadata
Title
The epothilone B analogue ixabepilone in patients with advanced hepatobiliary cancers: a trial of the University of Chicago Phase II Consortium
Authors
Halla S. Nimeiri
Deepti A. Singh
Kristen Kasza
David A. Taber
Rafat H. Ansari
Everett E. Vokes
Hedy L. Kindler
Publication date
01-12-2010
Publisher
Springer US
Published in
Investigational New Drugs / Issue 6/2010
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-009-9297-6

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