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Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

This study has been terminated.
(Poor patient accrual. Attempts to open at other sites unsuccessful.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00601926
First Posted: January 28, 2008
Last Update Posted: June 15, 2015
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Paul Monk, Ohio State University Comprehensive Cancer Center
Results First Submitted: June 20, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Kidney Cancer
Intervention: Biological: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bevacizumab

15 mg/kg over 90 minutes

bevacizumab: 15 mg/kg over 90 minutes every 3 weeks


Participant Flow:   Overall Study
    Bevacizumab
STARTED   5 
COMPLETED   5 
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

15 mg/kg over 90 minutes

bevacizumab: 15 mg/kg over 90 minutes every 3 weeks


Baseline Measures
   Bevacizumab 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   4 
>=65 years   1 
Gender 
[Units: Participants]
 
Female   0 
Male   5 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   5 
More than one race   0 
Unknown or Not Reported   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   5 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.   [ Time Frame: Up to 2 years ]

2.  Primary:   Response Rate to Bevacizumab in This Population.   [ Time Frame: Up to 2 years ]

3.  Secondary:   Safety of Bevacizumab in This Population of Patients   [ Time Frame: Up to 2 years ]


  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
This trial closed early due to poor patient accrual. Attempts to open this trial at other sites were not successful.


  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: Paul Monk, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-2886
e-mail: Paul.Monk@osumc.edu



Responsible Party: Paul Monk, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00601926     History of Changes
Other Study ID Numbers: OSU-06111
NCI-2011-03160 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
First Submitted: January 22, 2008
First Posted: January 28, 2008
Results First Submitted: June 20, 2014
Results First Posted: February 18, 2015
Last Update Posted: June 15, 2015