Phase II trial of ixabepilone (IXA) plus cetuximab (C) as first-line therapy for advanced pancreatic carcinoma (PC).

4086 Background: Progress in the management of PC is desperately needed. Non-gemcitabine based regimens are understudied. IXA has demonstrated activity in preclinical PC models including synergistic activity in combination with C. In a phase II cooperative group study in chemo-naive PC patients (pts) IXA showed promising efficacy. Here we present the results of a phase II, open label trial of IXA plus C as first line therapy for metastatic PC. Methods: Previously untreated pts (KPS 70–100) witheither locallyadvanced (LA) or metastatic (M) PC, were treated with IXA (32 mg/m2) IV over 3h on day 1 every 3 weeks and C, 400 mg/m2 IV (day 1) followed by weekly 250 mg/m2 doses. Pts were treated to progression or unacceptable toxicity. The primary endpoint was six month survival rate. The study tested the null hypothesis that the true 6-month rate ≤ 50% versus the alternative that the true rate > 70%. Results: Fifty-four pts (male/female 35/19; median age 63, range 47–84; LA/M 4/50) were enrolled in the study. A ...