Cetuximab + Gemox in Biliary Tract Cancer

Status Completed

Clinical Trial 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.

Clinical Trial Description

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) ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01216345
Study type	Interventional
Source	Association of Research on the Biology of Liver Tumors
Contact
Status	Completed
Phase	Phase 2
Start date	October 2006
Completion date	October 2009

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