Erbitux Monotherapie bei Patienten mit lokoregional nicht behandelbarem Hepatozellulären Karzinom - Cetuximab Monotherapie beim HCC
- Conditions
- advanced hepatocellular carcinoma (hcc) not amandable to regional therapies or metastatic disease
- Registration Number
- EUCTR2005-000040-85-DE
- Lead Sponsor
- Medical School Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: anti-tumor activity of Cetuximab in advanced/metastatic HCC;Secondary Objective: evaluation of p27Kip1 as a surrogate marker for EGFR-inhibition<br>correlation of biomarker and clinical outcome<br>documentation of clinical toxicity in patients with hepatic dysfunction;Primary end point(s): progression free survival after 6 months <br>overall survival<br>objective response rate
- Secondary Outcome Measures
Name Time Method