NCT01175733

Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether the addition of panitumumab to radiotherapy plus gemcitabine will increase the number of patients who are alive and progression free at 7 months.

Detailed description

This is a phase I/II, multi-center dose escalation study. Phase I: Patients will be enrolled in cohorts of 3 per dose level until the MTD of panitumumab has been established. Phase II: 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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	During the first 6 weeks Panitumumab will be administered weekly in combination with radiotherapy plus gemcitabine. From week 8 and further gemcitabine will be administered as monotherapy until disease progression or unacceptable toxicity, for a maximum duration of 1 year.

Timeline

• Start date: 2010-07-08
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2010-08-05
• Last updated: 2017-03-20

Locations

1 site across 1 country: Netherlands