advanced hepatocellular carcinoma (hcc) not amandable to regional therapies or metastatic disease
Conditions
Interventions
Trade Name: Erbitux
Product Code: EMD271786
Pharmaceutical Form: Intravenous infusion
Sponsors
Medical School Hannover
Medical School Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: advanced disease not amandable to regional therapies metastatic disease measurable disease adequate hematological, renal and hepatic function written informed consent >18 years ECOG peformance status 2 or less Life expectancy at least 3 months failure of regional therapy at least 6 weeks prior to study treatment adequate contraception 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: second malignancy within prior 5 years (exept basalioma, Cis of Cervix uteri) severe medical condition gravidity or lactation thrombosis or severe bleeding within 6 months prior to study inclusion major sugery within 4 weeks prior to study treatment protracted wound heeling or ulcus prior anti-tumor therapy less than 4 weeks prior to study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: anti-tumor activity of Cetuximab in advanced/metastatic HCC;Secondary Objective: evaluation of p27Kip1 as a surrogate marker for EGFR-inhibition correlation of biomarker and clinical outcome documentation of clinical toxicity in patients with hepatic dysfunction;Primary end point(s): progression free survival after 6 months overall survival objective response rate | — |
Countries
Germany
Outcome results
None listed