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Bevacizumab in Advanced Hepatocellular Carcinoma

NCT ID: NCT00162669

Last Updated: 2006-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma

Keywords

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Hepatocellular carcinoma, advanced, bevacizumab, phase II, VGEF, neovascularization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Principal Investigators

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Valérie BOIGE, Dr

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Valerie Boige, MD

Role: CONTACT

Phone: 00 33 014-211-4308

Email: [email protected]

Jean-Pierre Pignon, MD, PhD

Role: CONTACT

Phone: 00 33 014-211-4565

Email: [email protected]

Facility Contacts

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Valérie BOIGE, Dr

Role: primary

References

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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.

Reference Type DERIVED
PMID: 22707516 (View on PubMed)

Other Identifiers

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HCC-Avastin

Identifier Type: -

Identifier Source: secondary_id

IGR 1123

Identifier Type: -

Identifier Source: org_study_id