Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study
Primary Objective(s) 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)
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
best overall response (according to RECIST 1.0)
overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded
after an average of 2 months
No
Austria: National Health and Medical Research Council
CCC 01
NCT01216345
October 2006
October 2009
Name | Location |
---|