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A Study of Avastin (Bevacizumab) and Transarterial Chemoembolisation (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: August 18, 2014
Last verified: August 2014

December 18, 2007
August 18, 2014
February 2008
May 2011   (final data collection date for primary outcome measure)
Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ] [ Designated as safety issue: No ]
Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Progression-free survival
Complete list of historical versions of study NCT00576199 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With an Objective Response [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ] [ Designated as safety issue: No ]
    An objective response was defined as a complete response or a partial response. A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
  • Time to Progression [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ] [ Designated as safety issue: No ]
    Time to progression was defined as the time from the first administration of study drug to the first documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
  • Overall Survival [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from the first administration of study drug to death.
  • Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ] [ Designated as safety issue: No ]
    A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the Baseline sum LD. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the LD) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the LD for all target lesions will be calculated and reported as the Baseline sum LD.
  • Tumor Necrosis [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ] [ Designated as safety issue: No ]
    Tumor necrosis was quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area was measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation in tumor after TACE was regarded as an indication of necrosis. Tumor necrosis was assessed at Baseline and 1 week prior to the next scheduled transarterial chemoembolisation (TACE) for the first 4 TACEs, then 1 week prior to every second TACE till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline.
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 Transarterial Chemoembolisation (TACE) Treatment in Patients With Liver Cancer
A Phase II Single Arm, Multi-centre Study of Bevacizumab (Avastin®) Pre- and Post-transarterial Chemoembolisation (TACE) Treatment for Localized Unresectable Hepatocellular Carcinoma (HCC)

This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE sessions until disease progression.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cancer
  • Drug: Bevacizumab
    Bevacizumab was supplied as a sterile liquid in single-use vials.
    Other Name: Avastin
  • Procedure: Transarterial chemoembolisation (TACE)

    TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization.

    Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE.

Experimental: Bevacizumab 5 mg/kg
Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
Interventions:
  • Drug: Bevacizumab
  • Procedure: Transarterial chemoembolisation (TACE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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 1 measurable lesion, and overall tumor lesions occupying < 50% of liver volume
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

  • Patients receiving concurrent radiotherapy or immunotherapy.
  • Patients who have received previous chemotherapy, biological agents, or radiotherapy.
  • Prior transarterial chemoembolisation (TACE) or transarterial embolisation (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
August 2014

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