title: A phase 2 trial of ixabepilone plus cetuximab in first-line treatment of metastatic pancreatic cancer.
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/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.affiliation: University of Miami Sylvester Comprehensive Cancer Center Miami, FL.
authors.forename: Caio M
authors.initials: CM
authors.lastname: Rocha Lima
authors.forename: Edward H
authors.initials: EH
authors.lastname: Lin
authors.forename: George P
authors.initials: GP
authors.lastname: Kim
authors.forename: Jeffrey K
authors.initials: JK
authors.lastname: Giguere
authors.forename: John
authors.initials: J
authors.lastname: Marshall
authors.forename: Mark
authors.initials: M
authors.lastname: Zalupski
authors.forename: Chris
authors.initials: C
authors.lastname: Papageorgio
authors.forename: Miklos L
authors.initials: ML
authors.lastname: Auber
authors.forename: Remigiusz
authors.initials: R
authors.lastname: Kaleta
authors.forename: M Brent
authors.initials: MB
authors.lastname: McHenry
authors.forename: Ovidiu C
authors.initials: OC
authors.lastname: Trifan
authors.forename: Philip A
authors.initials: PA
authors.lastname: Philip