Gemcitabine and cetuximab in patients with advanced or metastatic biliary tract cancer

Trial Status Study closed : 44 included patients
Phase Phase II
Type of cancer advanced cholangiocarcinoma
Study design

One arm, open label, Simon two step design



Progression-free survival at 24 weeks.


  • Response rate
  • Tolerability
  • Overall survival
Inclusion Main criteria
  • 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
Exclusion Main criteria
  • 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
Treatment schedule

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

Study Period

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)

Study Coordinators

UCL St Luc, Prof. Dr. Borbath

Participating Groups


Participating centres

1)       UCL St-Luc

2)       UZ Leuven

3)       Hôpital Erasme

4)       CHU Sart-Tilman

5)       UZ Gent

6)       Ziekenhuis Osst-Limburg

7)       CH Jolimont

8)       AZ Groeninge

9)       CHR Citadelle

10)   Heilig Hart Ziekenhuis Roeselare

11)   Institut Jules Bordet


Protocol summary
NCT number NCT00747097
EudraCT 2007-005850-22
Interest to participate
More info