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A phase 2 trial of ixabepilone plus cetuximab in first-line treatment of metastatic pancreatic cancer
Authors
Miklos L. Auber
Jeffrey K. Giguere
+10 more
Remigiusz Kaleta
George P. Kim
Edward H. Lin
John Marshall
M. Brent Mchenry
Chris Papageorgio
Philip A. Philip
Caio M. Rocha Lima
Ovidiu C. Trifan
Mark Zalupski
Publication date
1 January 2012
Publisher
Health Sciences Research Commons
View
on
PubMed
Abstract
BACKGROUND: The aim of this phase 2 study was to evaluate the safety and efficacy of ixabepilone plus cetuximab in patients with advanced pancreatic cancer. METHODS: Eligible patients had advanced pancreatic adenocarcinoma that was metastatic or not amenable to resection, a Karnofsky performance status ≥70%, and no prior therapy for advanced disease. Patients received ixabepilone 32 mg/m2 (3-hour IV infusion) every 3 weeks and cetuximab 250 mg/m2 (1-hour IV infusion) weekly. The primary efficacy end point was the 6-month survival rate. Secondary end points included tumor response rate, overall survival, progression- free survival, and tolerability. RESULTS: A total of 54 patients were enrolled on this study. The 6-month survival rate was 57% (31/54:95% CI: 43-71%) with a median overall survival of 7.6 months (95% CI: 5.5-12.2 months). Patients who developed acneiform rash (n = 36) had a median survival of 8.8 months, compared with 2.6 months for those without rash (n = 18). Of 31 patients with measurable disease (defined as response-evaluable), 4 had confirmed partial responses and an additional 24 had stable disease. The combination was generally well-tolerated with the most common grade 3/4 hematological toxicities being leucopenia (39%) and neutropenia (33%). The most common grade 3/4 nonhematologic toxicity was fatigue (17%). CONCLUSIONS: The combination of ixabepilone and cetuximab was active and had acceptable toxicity. The efficacy results are similar to single-agent ixabepilone and gemcitabine-based combination therapies in patients with advanced pancreatic cancer. Exploratory analyses suggest a trend toward improved survival for patients who experienced rash. Gastrointest Cancer Res 5:155-160. © 2012 by International Society of Gastrointestinal Oncology
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Last time updated on 23/03/2021