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Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00287222
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : July 15, 2011
Last Update Posted : July 15, 2011
Genentech, Inc.
Information provided by:
University of Arkansas

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Interventions: Drug: Bevacizumab
Drug: Erlotinib

  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
Bevacizumab and Erlotinib Subjects will be treated with bevacizumab and erlotinib

Participant Flow:   Overall Study
    Bevacizumab and Erlotinib

  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
Bevacizumab and Erlotinib Subjects will be treated with bevacizumab and erlotinib

Baseline Measures
   Bevacizumab and Erlotinib 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   14 
>=65 years   7 
[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

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

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

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

Responsible Party: Rangaswamy Govindarajan, UAMS
ClinicalTrials.gov Identifier: NCT00287222     History of Changes
Other Study ID Numbers: UARK 2005-13
First Submitted: February 3, 2006
First Posted: February 6, 2006
Results First Submitted: March 22, 2011
Results First Posted: July 15, 2011
Last Update Posted: July 15, 2011