Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00459979
First received: April 11, 2007
Last updated: February 4, 2014
Last verified: February 2014
Results First Received: November 19, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Cancer
Interventions: Drug: sunitinib malate
Procedure: conventional surgery

  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
Sunitinib

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy


Participant Flow:   Overall Study
    Sunitinib  
STARTED     30  
COMPLETED     28  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Protocol Violation                 1  



  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.
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Reporting Groups
  Description
Sunitinib

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy


Baseline Measures
    Sunitinib  
Number of Participants  
[units: participants]
  30  
Age  
[units: Years]
Median ( Full Range )
 
Median age     61  
  ( 37 to 80 )  
Gender  
[units: participants]
 
Female     9  
Male     21  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     28  
Unknown or Not Reported     2  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     27  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
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1.  Primary:   Response to Sunitinib Therapy   [ Time Frame: 1 year from start of treatment ]

2.  Secondary:   The Number of Patients With Any Type of Complication or Adverse Event   [ Time Frame: 1 year from start of treatment ]

3.  Secondary:   Progression Free Survival   [ Time Frame: 1 year from start of treatment ]

4.  Secondary:   Percent Decrease of Diameter of Primary Tumors   [ Time Frame: 1 year from start of treatment ]

5.  Secondary:   Number of Tumors Which Decreased in Size   [ Time Frame: 1 year from start of treatment ]

6.  Secondary:   Number of Tumors With 30% Reduction in Size   [ Time Frame: 1 year from start of treatment ]

7.  Secondary:   Median Size Reduction Among Tumors With Some Shrinkage   [ Time Frame: 1 year from start of treatment ]


  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: Dr. Brian Rini
Organization: CCCC
phone: 216-444-9567
e-mail: rinib2@ccf.org


No publications provided by Case Comprehensive Cancer Center

Publications automatically indexed to this study:

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00459979     History of Changes
Other Study ID Numbers: CASE17806, P30CA043703, CASE-17806, CASE-17806-CC209
Study First Received: April 11, 2007
Results First Received: November 19, 2013
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration