A Study of Avastin (Bevacizumab) and TACE Treatment in Patients With Liver Cancer.

This study is currently recruiting participants.

Verified by Hoffmann-La Roche, April 2009

First Received: December 18, 2007 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00576199

Purpose

This single arm, open label study will assess the efficacy and safety of Avastin treatment combined with transarterial chemoembolisation (TACE) in patients with localised unresectable liver cancer. Patients will be treated with TACE at 8 or 10 week intervals, and Avastin 5mg/kg iv will be administered 24-48 hours prior to first TACE and every 2 weeks thereafter. The anticipated time on study treatment is until disease progression or unmanageable toxicity, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Liver Cancer	Drug: bevacizumab [Avastin]	Phase II

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	'An Open Label Study of the Effect of Avastin Pre- and Post-Transarterial Chemoembolisation (TACE) Treatment on Progression-Free Survival in Patients With Localized Unresectable Hepatocellular Carcinoma.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate, time to progression, disease control rate, overall survival, tumor necrosis rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	February 2008
Estimated Study Completion Date:	June 2011

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 5mg/kg iv every 2 weeks

Eligibility

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

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
liver cancer, not suitable for resection;
at least one measurable lesion, and overall tumor lesions occupying <50% of liver volume;
ECOG performance status 0-2.

Exclusion Criteria:

patients receiving concurrent radiotherapy or immunotherapy;
patients who have received previous chemotherapy, biological agents or radiotherapy;
prior TACE or TAE;
prior liver transplantation or liver resection;
current or recent (within 10 days of study start) use of full-dose anticoagulants for therapeutic purposes;
patients with high risk esophageal/gastric varices.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576199

Contacts

Contact: Please reference Study ID Number: ML21358	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

China
	Recruiting
HONG KONG, China, 852
	Recruiting
HONG KONG, China

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21358
Study First Received:	December 18, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00576199 History of Changes
Health Authority:	Hong Kong: Department of Health

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Disease Progression

Gastrointestinal Neoplasms
Bevacizumab
Hepatocellular Carcinoma
Angiogenesis Inhibitors
Carcinoma

Additional relevant MeSH terms:

Liver Diseases
Digestive System Neoplasms
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions

Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009