Bevacizumab in Advanced Hepatocellular Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00162669
First received: September 8, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Drug: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Estimated Enrollment: 50
Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162669

Contacts
Contact: Valerie Boige, MD 00 33 014-211-4308 boige@igr.fr
Contact: Jean-Pierre Pignon, MD, PhD 00 33 014-211-4565 jppignon@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Valérie BOIGE, Dr    00 33 014 211 43 08    boige@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Hoffmann-La Roche
Investigators
Principal Investigator: Valérie BOIGE, Dr Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided by Gustave Roussy, Cancer Campus, Grand Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00162669     History of Changes
Other Study ID Numbers: IGR 1123, HCC-Avastin
Study First Received: September 8, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on September 22, 2014