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

Abstract:

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/m(2), 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.

journal_name

Invest New Drugs

authors

Nimeiri HS,Singh DA,Kasza K,Taber DA,Ansari RH,Vokes EE,Kindler HL

doi

10.1007/s10637-009-9297-6

subject

Has Abstract

pub_date

2010-12-01 00:00:00

pages

854-8

issue

6

eissn

0167-6997

issn

1573-0646

journal_volume

28

pub_type

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