Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT01175733
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2010-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer
Sponsor:
Amsterdam UMC, location VUmc
Organization:
Study Overview
Official Title:
Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vectibix
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: