Status:
UNKNOWN
Bevacizumab in Advanced Hepatocellular Carcinoma
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary liver cancer (hepatocellular carcinoma) is the fifth most common malignant disorder, with an increasing incidence in Europe and the USA as a result of the high prevalence of hepatitis C. Most ...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven HCC or alpha-fetoprotein level \> 400 ng/ml together with hypervascular tumor and cirrhosis documented by CT scan or MRI.
- HCC not amenable to curative treatment (resection, transplantation, percutaneous ablation)
- Presence of at least one dimensionally measurable target lesion with largest diameter \>= 2 cm.
- No previous chemoembolization, no previous radiotherapy
- Cancer of the Liver Italian Program (CLIP) score \< 4
- World Health Organization (WHO) performance status of 2 or less
- Life expectancy \>= 3 months.
- Age \>= 18 years.
- Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; platelet count, at least 75,000 per cubic millimetre; Hemoglobin, at least 8 g/dl)
- Adequate liver function (bilirubin, not more than 2 times the upper limit of normal); Adequate renal function (serum creatinine, less than 150 micromol per liter)
- Adequate coagulation function
- Written informed consent
Exclusion
- Decompensated cirrhosis (Child-Pugh score \> 7)
- CLIP score \> 4
- Variceal bleeding during the previous 3 months
- Thromboembolic event during the previous 6 months
- Medical condition requiring full dose anticoagulation or anti-platelet drugs
- Abnormal cardiac function with history of ischemic heart disease in the previous 6 months, uncontrolled hypertension, unstable angina, severe cardiac arrhythmia,
- No brain metastasis, No bone metastasis only
- Previous or current malignancies at other sites
- No concomitant antitumor treatment including tamoxifen or somatostatin analogs
- Unstable systemic diseases or active uncontrolled infections.
- Patients (male and female) not using effective contraception if of reproductive potential.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00162669
Start Date
May 1 2005
Last Update
September 8 2006
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800