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: Caio M Rocha Lima, Edward H Lin, George P Kim, Jeffrey K Giguere, John Marshall, Mark Zalupski, Chris Papageorgio, Miklos L Auber, Remigiusz Kaleta, M Brent McHenry, Ovidiu C Trifan, Philip A Philip
• Journal: Gastrointestinal cancer research : GCR (Gastrointest Cancer Res) Vol. 5 Issue 5 Pg. 155-60 (Sep 2012) ISSN: 1934-7987 [Electronic] United States
• PMID: 23112883 (Publication Type: Journal Article)