Bevacizumab in Treating Patients With Unresectable Nonmetastatic Liver Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00055692
First received: March 6, 2003
Last updated: January 29, 2016
Last verified: December 2012
Results First Received: August 25, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Primary Hepatocellular Carcinoma
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Intervention: Biological: bevacizumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 46 patients were enrolled between February 2003 and September 2006

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
Treatment (Bevacizumab)

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally


Participant Flow:   Overall Study
    Treatment (Bevacizumab)  
STARTED     46  
COMPLETED     46  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Treatment (Bevacizumab)

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally


Baseline Measures
    Treatment (Bevacizumab)  
Number of Participants  
[units: participants]
  46  
Age  
[units: years]
Median (Full Range)
  58  
  (21 to 81)  
Gender  
[units: participants]
 
Female     8  
Male     38  
Race/Ethnicity, Customized  
[units: participants]
 
White     25  
Black     2  
Hispanic     5  
Asian     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: At 6 months ]

2.  Primary:   Disease Response   [ Time Frame: MRI is required at weeks 8, 16 and then every 12 weeks until disease progression ]

3.  Primary:   Mean Arterial Enhancement, Per Lesion, as Determined by Dynamic Gadolinium-enhanced Magnetic Resonance Imaging (MRI), Before and Following Bevacizumab Therapy.   [ Time Frame: Baseline and 8 weeks after bevacizumab therapy ]

4.  Primary:   Assessment on Circulating Levels of VEGF Which Also Contribute to HCC Pathogenesis and on Potential Alterations of These Levels in the Setting of VEGF-inhibition   [ Time Frame: During treatment ]

5.  Primary:   To Collect Information on Hepatic Function and Hepatitis Viral Activity in Cirrhosis and Upon Potential Alterations in the Setting of VEGF-inhibition   [ Time Frame: During and after treatment ]

6.  Other Pre-specified:   Disease Stability   [ Time Frame: At 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa Escobar-Peralta, Program Manager
Organization: Montefiore Medical Center
phone: 718-379-6866
e-mail: lescobar@montefiore.org


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00055692     History of Changes
Other Study ID Numbers: NCI-2012-02518
NCI-2012-02518 ( Other Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-5611 ( Other Identifier: NCI/CTEP )
5611 ( Other Identifier: CTEP )
P30CA013330 ( US NIH Grant/Contract Award Number )
N01CM62204 ( US NIH Grant/Contract Award Number )
N01CM62203 ( US NIH Grant/Contract Award Number )
Study First Received: March 6, 2003
Results First Received: August 25, 2015
Last Updated: January 29, 2016
Health Authority: United States: Food and Drug Administration