ECHO

One arm, open label, Simon two step design

Primary

Progression-free survival at 24 weeks.

Secondary

• Response rate
• Tolerability
• Overall survival

• Histologically/cytologically proven advanced (non-operable /metastatic) CCK
• Measurable disease, according to RECIST criteria
• life expectancy of at least 12 weeks
• Age>18
• WHO PS 0 or 1 at study entry
• Adequate liver, renal and hematopoietic functions
• Adequate biliary drainage if mandatory
• effective contraception for both male and female patients if the risk of contraception exists

• uncontrolled concurrent CNS, cardiac, infectious diseases, HIV
• previous malignancy in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix
• No previous chemotherapy for their disease
• Known hypersensitivity to cetuximab

Product: Cetuximab

Dosing schedule:  400 mg/m² for the 1st injection, then 250 mg/m² every week

Mode of administration: IV

Product: Gemcitabine

Dosing schedule:  1000 mg/m² every week, 3 weeks/4

Mode of administration:  IV

Enrolment start date: Q1/2008

Enrolment finish date: Q3/2009

Treatment period end date: Q1/2010

Follow-up period end date: Q3-Q4/2010

Publication in "Annals of Oncology » (see documents at the top of this page)

UCL St Luc, Prof. Dr. Borbath

BGDO