Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395252
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2006-11-01
Brief Title:
Safety and Efficacy Therapy of Gemcitabine and Erbitux to R0 or R1 Resected Pancreatic Cancer
Sponsor:
Carmen Schade-Brittinger
Organization:
Philipps University Marburg Medical Center
Study Overview
Official Title:
Multicenter Phase II-trial to Investigate Safety and Efficacy of an Adjuvant Therapy With Gemcitabine and Erbitux in Patients With R0 or R1 Resected Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
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:
ATIP
Brief Summary:
This is an open-label non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer
Detailed Description:
Available study data indicated a possible benefit from adjuvant chemotherapy for patients with resected pancreatic cancer The optimal therapy regimen has yet to be determined
Based on the experiences with cetuximab Erbituxand gemcitabine in advanced pancreatic cancer and with gemcitabine as adjuvant therapy the aim of this study was to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0 or R1-resectable pancreatic cancer and to evaluate if the disease free survival can be increased by the addition of an EGFR-targeted therapy
Based on the experiences with cetuximab Erbituxand gemcitabine in advanced pancreatic cancer and with gemcitabine as adjuvant therapy the aim of this study was to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0 or R1-resectable pancreatic cancer and to evaluate if the disease free survival can be increased by the addition of an EGFR-targeted therapy
Study Oversight
Has Oversight DMC:
None
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?:
None