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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576199
First received: December 18, 2007
Last updated: October 7, 2013
Last verified: October 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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 ]

Enrollment: 29
Study Start Date: February 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
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: NCT00576199

Locations
Hong Kong
Hong Kong, Hong Kong, 0
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576199     History of Changes
Other Study ID Numbers: ML21358
Study First Received: December 18, 2007
Last Updated: October 7, 2013
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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 July 24, 2014