Clinical trialPhase 1 / Phase 2Completed
Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 8 July 2010
- Expected end
- May 2016
- Enrollment
- 18 participants
- Sites
- 1
- Primary outcomes
- Phase I: the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab.; Phase II: the proportion of patients that is alive and progression-free at 7 months.; Phase II: safety and tolerability
- Sponsor
- Other
- Results posted
- No
- Last update
- 20 March 2017
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.