Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study

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