Phase I Clinical Trial to Determine the Feasibility and Maximum Tolerated Dose of Panitumumab to Standard Gemcitabine-Based Chemoradiation in Locally Advanced Pancreatic Cancer

摘要: Purpose: Epidermal growth factor receptor (EGFR) inhibitors may improve both the therapeutic efficacy of radiotherapy and radiosensitizing activity gemcitabine. Based on this rationale nonoverlapping toxicity profiles gemcitabine monoclonal EGFR antibody panitumumab, we designed a phase I trial to investigate maximum-tolerated dose (MTD), safety, panitumumab added gemcitabine-based chemoradiotherapy (CRT) in patients with locally advanced pancreatic cancer (LAPC). Patients Methods: LAPC WHO performance status 0 1 were treated weekly at four levels (1–2.5 mg/kg), combined 300 mg/m 2 (50.4 Gy 28 fractions) for 6 weeks, followed by 1,000 3 weeks every 4 until disease progression or unacceptable toxicity. Each cohort was monitored during combination therapy establish limiting Tumor evaluation performed after CRT monotherapy. Results: Fourteen enrolled; 14 evaluable 13 response. The MTD 1.5 mg/kg. Three patients, MTD, experienced grade adverse events therapy; neutropenia ( n = 2; 33%), fatigue 1; 17%), nausea vomiting 17%). Partial response achieved (23%), each cohort. Median free survival three cohorts together 8.9 months. Conclusion: addition has manageable potential clinical efficacy. Clin Cancer Res; 1–7. ©2015 AACR.