search
Back to results

Bevacizumab in Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
bevacizumab
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, advanced, bevacizumab, phase II, VGEF, neovascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Gustave RoussyRecruiting

Outcomes

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

Full Information

First Posted
September 8, 2005
Last Updated
September 7, 2006
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00162669
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, advanced, bevacizumab, phase II, VGEF, neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bevacizumab
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Overall survival, progression-free survival, toxicity (National Cancer Institute-Common Toxicity Criteria Version 3 [NCI-CTC V3])
Title
Evaluation of vascular changes will be performed using Doppler ultrasound with injection of sonographic contrast agent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Boige, MD
Phone
00 33 014-211-4308
Email
boige@igr.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pierre Pignon, MD, PhD
Phone
00 33 014-211-4565
Email
jppignon@igr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie BOIGE, Dr
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie BOIGE, Dr
Phone
00 33 014 211 43 08
Email
boige@igr.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
22707516
Citation
Boige V, Malka D, Bourredjem A, Dromain C, Baey C, Jacques N, Pignon JP, Vimond N, Bouvet-Forteau N, De Baere T, Ducreux M, Farace F. Efficacy, safety, and biomarkers of single-agent bevacizumab therapy in patients with advanced hepatocellular carcinoma. Oncologist. 2012;17(8):1063-72. doi: 10.1634/theoncologist.2011-0465. Epub 2012 Jun 15.
Results Reference
derived

Learn more about this trial

Bevacizumab in Advanced Hepatocellular Carcinoma

We'll reach out to this number within 24 hrs