Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell 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. Identifier: NCT00113217
Recruitment Status : Completed
First Posted : June 7, 2005
Results First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Renal Cell Carcinoma
Kidney Cancer
Intervention: Drug: Bevacizumab

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

Participant Flow:   Overall Study

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (35 to 83) 
[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.  

  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
No text entered.

  More Information

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

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00113217     History of Changes
Other Study ID Numbers: 2003-0982
First Submitted: June 6, 2005
First Posted: June 7, 2005
Results First Submitted: September 4, 2013
Results First Posted: January 14, 2014
Last Update Posted: January 14, 2014