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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase

Completed

Phase 2

Conditions

Time to Progression

Treatments

Drug: gemcitabine + cetuximab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00747097

62202-788

Details and patient eligibility

About

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.

Enrollment

43 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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