Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer
This is a phase I/II, multi-center dose escalation study.
Patients will be enrolled in cohorts of 3 per dose level until the MTD of panitumumab has
Up to approximately 56 patients will be treated at the MTD level of panitumumab as
established in the phase I part of the study.
Based on the historic data of patients with pancreatic cancer treated with gemcitabine based
chemoradiation, we aim to increase the number of patients who are alive and progression free
at 7 months from the historical value of 50% to 70% with the combination treatment of
chemoradiation plus panitumumab.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab.
During the phase I part of the study, we have planned to study four dose levels of panitumumab if no MTD is being derived before the final dose level. Patients will be enrolled in cohorts of 3 per dose level. If there are no dose-limiting toxicities (DLTs) experienced by the first 3 patients in a cohort during the first 43 days after the first study treatment, additional patients will be entered in the next dose level. At the final dose level recommended for the phase II study a minimum of 6 patients will be treated.
Henk MW Verheul, MD, PhD
VU University Medical Center
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)