Chemoembolization and Bevacizumab in Treating Patients With Liver Cancer That Cannot Be Removed With Surgery

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00049322
First received: November 12, 2002
Last updated: February 17, 2016
Last verified: February 2016
Results First Received: January 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver Cancer
Intervention: Biological: bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
date of recruitment period August 2003- October 2008. Types of location: Academic medical clinics and community medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (TACE-BEV Arm)

Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.

Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.

Arm II (TACE-O Arm ) Observation

Participant Flow:   Overall Study
    Arm I (TACE-BEV Arm)     Arm II (TACE-O Arm )  
STARTED     15     15  
COMPLETED     14     9  
NOT COMPLETED     1     6  
disease burden                 0                 3  
Adverse Event                 1                 0  
refused angio                 0                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (TACE-BEV Arm)

Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.

Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.

Arm II (TACE-O Arm ) Observation
Total Total of all reporting groups

Baseline Measures
    Arm I (TACE-BEV Arm)     Arm II (TACE-O Arm )     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age, Customized  
[units: years]
Median (Full Range)
     
Median age     61  
  (50 to 79)  
  58  
  (49 to 75)  
  59.5  
  (49 to 79)  
Gender  
[units: participants]
     
Female     2     3     5  
Male     13     12     25  



  Outcome Measures
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1.  Primary:   Neovessel Formation as Measured by Angiogram at 14 Weeks   [ Time Frame: 14 weeks ]

2.  Secondary:   Progression Free Survival   [ Time Frame: 16 weeks ]

3.  Secondary:   Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment   [ Time Frame: 16 weeks ]

4.  Secondary:   Assess Pharmakokinetics of Bevacizumab in Liver Disease   [ Time Frame: day 85 ]

5.  Secondary:   Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab   [ Time Frame: 21 days after TACE ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Size of study limits any strong conclusions regarding efficacy.Since this study was first designed and implemented, there have been many advances in the field, including confirmation of proof of principal for anti-angiogenic agents in advanced HCC.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Carolyn Britten, M.D.
Organization: University of California Los Angeles
phone: 310 829 4971
e-mail: cbritten@mednet.ucla.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00049322     History of Changes
Other Study ID Numbers: CDR0000258045
P30CA016042 ( US NIH Grant/Contract Award Number )
UCLA-0206060 ( Other Identifier: UCLA )
NCI-G02-2124 ( Other Identifier: NCI )
Study First Received: November 12, 2002
Results First Received: January 20, 2016
Last Updated: February 17, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration