Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Genentech
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00323739
First received: May 5, 2006
Last updated: July 18, 2013
Last verified: July 2013
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Cancer
Interventions: Drug: bevacizumab
Drug: RAD001

  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
Eighty-four patients with advanced kidney cancer were assessed for participation at multiple US clinics between August 2006 and November 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four patients did not meet eligibility criteria and were not treated.

Reporting Groups
  Description
Bevacizumab and Everolimus Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.

Participant Flow:   Overall Study
    Bevacizumab and Everolimus  
STARTED     80  
COMPLETED     80  
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 and Everolimus Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.

Baseline Measures
    Bevacizumab and Everolimus  
Number of Participants  
[units: participants]
  80  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     42  
>=65 years     38  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 10.4  
Gender  
[units: participants]
 
Female     20  
Male     60  
Region of Enrollment  
[units: participants]
 
United States     80  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease   [ Time Frame: 18 months ]

2.  Secondary:   Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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.  


Results Point of Contact:  
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


Publications of Results:

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00323739     History of Changes
Other Study ID Numbers: SCRI GU 32
Study First Received: May 5, 2006
Results First Received: December 19, 2012
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board