Ignite Creation Date:
2024-05-05 @ 10:55 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01216345
Status:
COMPLETED
Last Update Posted:
2010-10-07
First Post:
2010-10-04
Brief Title:
Cetuximab Gemox in Biliary Tract Cancer
Sponsor:
Association of Research on the Biology of Liver Tumors
Organization:
Association of Research on the Biology of Liver Tumors
Study Overview
Official Title:
Cetuximab Plus Gemcitabine-Oxaliplatin GEMOX in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer a Phase II Study
Status:
COMPLETED
Status Verified Date:
2010-10
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:
None
Brief Summary:
The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin GEMOX in the palliative first line treatment of biliary tract cancer BTC patients
Detailed Description:
Primary Objectives The primary objective of the study is to evaluate the best overall response of cetuximab in combination with gemcitabine and oxaliplatin GEMOX as first line treatment in patients with advanced or metastatic biliary tract cancer
Secondary Objectives
The secondary objectives of this study are as follows
toxicity
secondary resection rate
progression-free survival PFS
overall survival OS
Secondary Objectives
The secondary objectives of this study are as follows
toxicity
secondary resection rate
progression-free survival PFS
overall survival OS
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