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.

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)

Inclusion Criteria:

• histologically or cytologically proven unresectable advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic CC and gallbladder cancer)
• age ≥ 18 years
• ECOG performance status ≤ 2
• bidimensionally measurable disease per RECIST criteria
• no prior chemotherapy or targeted therapy for advanced disease
• adequate bone marrow reserve (neutrophil count > 1500 /µL, platelet count > 100,000 /µL)
• adequate renal function (serum creatinine ≤ 1.5 x the upper limit of normal)
• adequate hepatic function (serum bilirubin <2.5 x the upper limit of normal (ULN) and serum transaminase level of ≤ 5 x ULN)
• written informed consent

Exclusion Criteria:

• prior palliative treatment
• resectable disease
• brain metastases
• serious or uncontrolled concurrent medical illness
• pregnancy or nursing
• history of other malignancies with the exception of excised cervical or basal skin/squamous cell carcinoma
• peripheral neuropathy (grade > 1)