Bevacizumab in Advanced Hepatocellular Carcinoma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 8, 2005

Last Updated Date

September 7, 2006

Start Date ^†

May 2005

Current 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.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00162669 on ClinicalTrials.gov Archive Site

Current 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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Bevacizumab in Advanced Hepatocellular Carcinoma

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Hepatocellular Carcinoma

Intervention ^†

Drug: bevacizumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

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

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00162669

Responsible Party

Secondary IDs ^††

HCC-Avastin

Study Sponsor ^†

Institut Gustave Roussy

Collaborators ^††

Hoffmann-La Roche

Investigators ^†

Principal Investigator:

Valérie BOIGE, Dr

Institut Gustave Roussy

Information Provided By

Institut Gustave Roussy

Verification Date

September 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.