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

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

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