Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00287222
First received: February 3, 2006
Last updated: June 17, 2011
Last verified: June 2011
Results First Received: March 22, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Interventions: Drug: Bevacizumab
Drug: Erlotinib

  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
Recruitment Period was from 7/08/2005 to 12/17/2008. Recruitment occurred at the University of Arkansas for Medical Sciences medical oncology clinic and Kansas University Cancer Center.

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
Bevacizumab and Erlotinib Subjects will be treated with bevacizumab and erlotinib

Participant Flow:   Overall Study
    Bevacizumab and Erlotinib  
STARTED     21  
COMPLETED     21  
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
Bevacizumab and Erlotinib Subjects will be treated with bevacizumab and erlotinib

Baseline Measures
    Bevacizumab and Erlotinib  
Number of Participants  
[units: participants]
  21  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     7  
Gender  
[units: participants]
 
Female     8  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     21  



  Outcome Measures

1.  Primary:   Number of Participants Who Remained Free of Progression at the 27th Week.   [ Time Frame: 27 weeks ]


  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
Two subjects withdrew consent.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sandy Annis
Organization: University of Arkansas for Medical Sciences
phone: 5016868274
e-mail: amannis@uams.edu


No publications provided by University of Arkansas

Publications automatically indexed to this study:

Responsible Party: Rangaswamy Govindarajan, UAMS
ClinicalTrials.gov Identifier: NCT00287222     History of Changes
Other Study ID Numbers: UARK 2005-13
Study First Received: February 3, 2006
Results First Received: March 22, 2011
Last Updated: June 17, 2011
Health Authority: United States: Food and Drug Administration