Bevacizumab in Advanced Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00162669
Recruitment Status : Unknown
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : September 13, 2005
Last Update Posted : September 8, 2006
Hoffmann-La Roche
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

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 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: bevacizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment
Study Start Date : May 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Overall survival, progression-free survival, toxicity (National Cancer Institute-Common Toxicity Criteria Version 3 [NCI-CTC V3])
  2. Evaluation of vascular changes will be performed using Doppler ultrasound with injection of sonographic contrast agent

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162669

Contact: Valerie Boige, MD 00 33 014-211-4308
Contact: Jean-Pierre Pignon, MD, PhD 00 33 014-211-4565

Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Valérie BOIGE, Dr    00 33 014 211 43 08   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Hoffmann-La Roche
Principal Investigator: Valérie BOIGE, Dr Gustave Roussy, Cancer Campus, Grand Paris

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00162669     History of Changes
Other Study ID Numbers: IGR 1123
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2006

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Hepatocellular carcinoma, advanced, bevacizumab, phase II, VGEF, neovascularization

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents