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

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.
ClinicalTrials.gov Identifier: NCT00459979
Recruitment Status : Completed
First Posted : April 13, 2007
Results First Posted : January 7, 2014
Last Update Posted : March 7, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Kidney Cancer
Interventions: Drug: sunitinib malate
Procedure: conventional surgery

  Participant Flow

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
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

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
Sunitinib

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

conventional surgery : nephrectomy


Baseline Measures
   Sunitinib 
Overall Participants Analyzed 
[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

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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00459979     History of Changes
Other Study ID Numbers: CASE17806
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-17806 ( Other Identifier: Case Comprehensive Cancer Center )
CASE-17806-CC209 ( Other Identifier: Cancer Center IRB )
First Submitted: April 11, 2007
First Posted: April 13, 2007
Results First Submitted: November 19, 2013
Results First Posted: January 7, 2014
Last Update Posted: March 7, 2014