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

  • PHASE II STUDIES
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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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Authors and Affiliations

  1. Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, 676 North St. Clair Street, suite 850, Chicago, IL, 60611, USA

    Halla S. Nimeiri

  2. University of Chicago Medical Center, 5841 S. Maryland Ave., MC 2115, Chicago, IL, 60637, USA

    Deepti A. Singh, Everett E. Vokes & Hedy L. Kindler

  3. University of Chicago, 5841 S. Maryland Ave. MC 2007, Chicago, IL, 60637, USA

    Kristen Kasza

  4. Northern Indiana Cancer Research Consortium, 100Navarre Place Suite 5550, South Bend, IN, 46601, USA

    David A. Taber & Rafat H. Ansari

Authors
  1. Halla S. Nimeiri
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  2. Deepti A. Singh
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  3. Kristen Kasza
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  4. David A. Taber
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  5. Rafat H. Ansari
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  6. Everett E. Vokes
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  7. Hedy L. Kindler
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Correspondence to Halla S. Nimeiri.

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Supported by NCI grant N01-CM-17102

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Nimeiri, H.S., Singh, D.A., Kasza, K. et al. The epothilone B analogue ixabepilone in patients with advanced hepatobiliary cancers: a trial of the University of Chicago Phase II Consortium. Invest New Drugs 28, 854–858 (2010). https://doi.org/10.1007/s10637-009-9297-6

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  • DOI: https://doi.org/10.1007/s10637-009-9297-6

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