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/m(2) (3-hour IV infusion) every 3 weeks and cetuximab 250 mg/m(2) (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.
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/m(2) (3-hour IV infusion) every 3 weeks and cetuximab 250 mg/m(2) (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.
Authors: Volker Heinemann; Detlef Quietzsch; Frank Gieseler; Michael Gonnermann; Herbert Schönekäs; Andreas Rost; Horst Neuhaus; Caroline Haag; Michael Clemens; Bernard Heinrich; Ursula Vehling-Kaiser; Martin Fuchs; Doris Fleckenstein; Wolfgang Gesierich; Dirk Uthgenannt; Hermann Einsele; Axel Holstege; Axel Hinke; Andreas Schalhorn; Ralf Wilkowski Journal: J Clin Oncol Date: 2006-08-20 Impact factor: 44.544
Authors: Francis Y F Lee; Robert Borzilleri; Craig R Fairchild; Amrita Kamath; Richard Smykla; Robert Kramer; Gregory Vite Journal: Cancer Chemother Pharmacol Date: 2008-03-18 Impact factor: 3.333
Authors: Francis Y F Lee; Richard Smykla; Kathy Johnston; Krista Menard; Kelly McGlinchey; Russell W Peterson; Amy Wiebesiek; Gregory Vite; Craig R Fairchild; Robert Kramer Journal: Cancer Chemother Pharmacol Date: 2008-03-19 Impact factor: 3.333
Authors: Malcolm J Moore; David Goldstein; John Hamm; Arie Figer; Joel R Hecht; Steven Gallinger; Heather J Au; Pawel Murawa; David Walde; Robert A Wolff; Daniel Campos; Robert Lim; Keyue Ding; Gary Clark; Theodora Voskoglou-Nomikos; Mieke Ptasynski; Wendy Parulekar Journal: J Clin Oncol Date: 2007-04-23 Impact factor: 44.544
Authors: Henry Q Xiong; Arthur Rosenberg; Albert LoBuglio; William Schmidt; Robert A Wolff; John Deutsch; Michael Needle; James L Abbruzzese Journal: J Clin Oncol Date: 2004-07-01 Impact factor: 44.544
Authors: Richard Herrmann; György Bodoky; Thomas Ruhstaller; Bengt Glimelius; Emilio Bajetta; Johannes Schüller; Piercarlo Saletti; Jean Bauer; Arie Figer; Bernhard Pestalozzi; Claus-Henning Köhne; Walter Mingrone; Salomon M Stemmer; Karin Tàmas; Gabriela V Kornek; Dieter Koeberle; Susanne Cina; Jürg Bernhard; Daniel Dietrich; Werner Scheithauer Journal: J Clin Oncol Date: 2007-06-01 Impact factor: 44.544
Authors: Elizabeth Poplin; Yang Feng; Jordan Berlin; Mace L Rothenberg; Howard Hochster; Edith Mitchell; Steven Alberts; Peter O'Dwyer; Daniel Haller; Paul Catalano; David Cella; Al Bowen Benson Journal: J Clin Oncol Date: 2009-07-06 Impact factor: 44.544
Authors: Johan Vansteenkiste; Primo N Lara; Thierry Le Chevalier; Jean-Luc Breton; Philip Bonomi; Alan B Sandler; Mark A Socinski; Catherine Delbaldo; Brent McHenry; David Lebwohl; Ronald Peck; Martin J Edelman; Mark Edelman Journal: J Clin Oncol Date: 2007-07-02 Impact factor: 44.544
Authors: Dana M Roque; Eric R Siegel; Natalia Buza; Stefania Bellone; Dan-Arin Silasi; Gloria S Huang; Vaagn Andikyan; Mitchell Clark; Masoud Azodi; Peter E Schwartz; Gautam G Rao; Jocelyn C Reader; Pei Hui; Joan R Tymon-Rosario; Justin Harold; Dennis Mauricio; Burak Zeybek; Gulden Menderes; Gary Altwerger; Elena Ratner; Alessandro D Santin Journal: Br J Cancer Date: 2022-02-11 Impact factor: 7.640