Patients with advanced biliary tract cancer, excluding gallbladder cancer, where surgery is not feasible. MedDRA version: 9.1 Level: LLT Classification code 10008594 Term: Cholangiocarcinoma non-resectable
Conditions
Interventions
Trade Name: ERBITUX 5 mg/ml
Pharmaceutical Form: Solution for infusion
Trade Name: GEMZAR
Pharmaceutical Form: Injection*
Sponsors
BGDO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 conception exists Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Uncontrolled concurrent CNS, cardiac, infectious diseases, HIV Previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix No previous chemotherapy for their disease Known hypersensitivity to cetuximab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression-free survival;Secondary Objective: Response rate, overall survival, tolerability;Primary end point(s): To improve Progression-free survival, from 20% (efficacy obtained with gemcitabine alone) to 40% at 24 weeks with the combination gemcitabine-cetuximab. | — |
Countries
Belgium
Outcome results
None listed