The purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.

Inclusion Criteria:

• histologically or cytologically proven locally advanced or metastatic unresectable adenocarcinoma of the biliary tract
• signed written informed consent
• age > 18
• WHO PS 0 or 1 at study entry
• measurable (diameter ³ 1 cm) / evaluable disease, according to RECIST criteria
• adequate renal (serum creatinin<1.5x upper reference range), liver (total bilirubin<2x upper reference range) and hematopoietic functions (PMN>1,5x109/L, platelets>100x109/L)
• life expectancy of at least 12 weeks
• effective contraception throughout the study for both male and female patients if the risk of conception exists

Exclusion Criteria:

• uncontrolled concurrent CNS, cardiac, infectious diseases
• previous exposure to epidermal growth factor targeting therapy
• known hypersensitivity to any components of study treatments
• previous chemotherapy for this cancer
• previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
• pregnancy or breast feeding
• medical or psychological conditions that would not permit the patient to complete the study or sign informed consent