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

• Published in: Investigational new drugs Vol. 28; no. 6; pp. 854 - 858
• Main Authors: Nimeiri, Halla S., Singh, Deepti A., Kasza, Kristen, Taber, David A., Ansari, Rafat H., Vokes, Everett E., Kindler, Hedy L.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.12.2010; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Biliary Tract Neoplasms - drug therapy; Biliary Tract Neoplasms - pathology; Cancer; Chemotherapy; Epothilones - adverse effects; Epothilones - metabolism; Epothilones - therapeutic use; Female; Gallbladder; Humans; Kaplan-Meier Estimate; Liver Neoplasms - drug therapy; Liver Neoplasms - pathology; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Staging; Oncology; Ovarian cancer; Pharmacology/Toxicology; Phase II Studies; Treatment Outcome; Universities; Young Adult; Epothilone; Hepatobiliary cancers
• ISSN: 0167-6997; 1573-0646
• DOI: 10.1007/s10637-009-9297-6

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/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.