Bevacizumab in Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00162669
• Other study ID #: IGR 1123
• Secondary ID: HCC-Avastin
• Status: Recruiting
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: September 7, 2006
• Start date: May 2005

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Valerie Boige, MD
• Phone: 00 33 014-211-4308
• Email: boige[@]igr.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 patients are not suitable for potentially curative treatment. There is no standard palliative treatment for patients with advanced hepatocellular carcinoma (HCC), as no drug has been demonstrated to be efficient in this disease in terms of survival. The use of anti-vascular agents might be a promising approach in view of the highly vascular nature of this tumor. The aim of this phase II trial is to evaluate the potential benefit of bevacizumab in terms of disease control rate, progression-free and overall survival in adult patients with advanced primary liver cancer. Bevacizumab is an angiogenesis inhibitor already successfully used in patients with colorectal and renal cancers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• bevacizumab

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main response parameter will be the disease control rate, defined by the objective response and stable disease rate (Response Evaluation Criteria in Solid Tumors [RECIST criteria]) after two consecutive tumor evaluations during treatment.
Secondary	Overall survival, progression-free survival, toxicity (National Cancer Institute-Common Toxicity Criteria Version 3 [NCI-CTC V3])
Secondary	Evaluation of vascular changes will be performed using Doppler ultrasound with injection of sonographic contrast agent