Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00113217
First received: June 6, 2005
Last updated: December 2, 2013
Last verified: December 2013
Results First Received: September 4, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Renal Cell Carcinoma
Kidney Cancer
Intervention: Drug: 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
Recruitment Period: February 22, 2005 to April 4, 2008. All participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the fifty-two (52), two enrolled participants did not receive treatment and were excluded from the trial.

Reporting Groups
  Description
Bevacizumab 10 mg/kg intravenous (IV) Day 1 of 14-day cycle.

Participant Flow:   Overall Study
    Bevacizumab  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  



  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
Bevacizumab 10 mg/kg intravenous (IV) Day 1 of 14-day cycle.

Baseline Measures
    Bevacizumab  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 35 to 83 )  
Gender  
[units: participants]
 
Female     13  
Male     37  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: Up to 3 years (or until disease progression) ]

2.  Secondary:   Safety of Treatment   [ Time Frame: Following 56 days treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


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


Results Point of Contact:  
Name/Title: Eric Jonasch, MD / Associate Professor
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-2830
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00113217     History of Changes
Other Study ID Numbers: 2003-0982
Study First Received: June 6, 2005
Results First Received: September 4, 2013
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board