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

December 18, 2007
October 7, 2013
February 2008
May 2011   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Progression-free survival
Complete list of historical versions of study NCT00576199 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Overall response rate, time to progression, disease control rate, overall survival, tumor necrosis rate. Safety: AEs, laboratory parameters.
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) and TACE Treatment in Patients With Liver Cancer.
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cancer
Drug: bevacizumab [Avastin]
5mg/kg iv every 2 weeks
Experimental: 1
Intervention: Drug: bevacizumab [Avastin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00576199
ML21358
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP