NCT01216345

Cetuximab + Gemox in Biliary Tract Cancer

Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Association of Research on the Biology of Liver Tumors · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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)

Conditions

• Unresectable
• Locally Advanced
• Metastatic

Interventions

Type	Name	Description
DRUG	Cetuximab + Gemcitabine + Oxaliplatin	Cetuximab 500mg/m2, iv every two weeks Gemcitabine 1000mg/m2, iv every two weeks Oxaliplatin 100mg/m2, iv every two weeks

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-10-01
• Completion: 2009-10-01
• First posted: 2010-10-07
• Last updated: 2010-10-07

Locations

1 site across 1 country: Austria