A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00796757
First received: November 21, 2008
Last updated: May 22, 2015
Last verified: May 2015
Results First Received: August 4, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Cell Cancer
Interventions: Drug: bevacizumab [Avastin]
Drug: interferon alfa-2a

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bevacizumab Plus (+) Interferon Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 and Interferon alpha-2a (IFN) 3 million international units (MIU) subcutaneously (SC) 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.

Participant Flow:   Overall Study
    Bevacizumab Plus (+) Interferon  
STARTED     146  
COMPLETED     60  
NOT COMPLETED     86  
Withdrawal by Subject                 14  
Death                 61  
Protocol Violation                 1  
Participant noncompliance                 1  
Investigator's decision                 2  
Not specified                 7  



  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.
Intent-to-treat (ITT) population: All participants who received at least 1 dose of either or both study drugs and had a valid baseline assessment and at least 1 postbaseline assessment.

Reporting Groups
  Description
Bevacizumab + Interferon Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.

Baseline Measures
    Bevacizumab + Interferon  
Number of Participants  
[units: participants]
  146  
Age  
[units: years]
Mean (Standard Deviation)
  61.1  (10.37)  
Gender  
[units: participants]
 
Female     48  
Male     98  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months   [ Time Frame: 12 and 24 months ]

2.  Primary:   PFS - Percentage of Participants With an Event   [ Time Frame: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant ]

3.  Primary:   PFS - Time to Event   [ Time Frame: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant ]

4.  Secondary:   Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)   [ Time Frame: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant ]

5.  Secondary:   Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months   [ Time Frame: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant ]

6.  Secondary:   OS - Percentage of Participants With an Event   [ Time Frame: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant ]

7.  Secondary:   OS - Time to Event   [ Time Frame: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant ]

8.  Secondary:   Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit   [ Time Frame: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT) ]

9.  Secondary:   EQ-5D - Visual Analog Scale (VAS)   [ Time Frame: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT ]


  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:  
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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00796757     History of Changes
Other Study ID Numbers: MO21609, 2007-006611-23
Study First Received: November 21, 2008
Results First Received: August 4, 2014
Last Updated: May 22, 2015
Health Authority: Czech Republic: State Institute for Drug Control