Sorafenib in Treating Patients Who Are Undergoing Surgery for Metastatic Kidney Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00126659
First received: August 2, 2005
Last updated: April 21, 2014
Last verified: December 2012
Results First Received: September 28, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions: Procedure: therapeutic conventional surgery
Drug: sorafenib tosylate
Other: laboratory biomarker analysis

  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
Recruitment Period: January 11, 2006 to July 12, 2007. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This trial was run at the same time as a competing trial and suffered from poor accrual. For that reason it was closed.

Reporting Groups
  Description
Cytoreductive Nephrectomy Day 0 Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
Sorafenib + Cytoreductive Nephrectomy Day 8 Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
Sorafenib + Cytoreductive Nephrectomy Day 29 Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib

Participant Flow:   Overall Study
    Cytoreductive Nephrectomy Day 0     Sorafenib + Cytoreductive Nephrectomy Day 8     Sorafenib + Cytoreductive Nephrectomy Day 29  
STARTED     3     3     4  
COMPLETED     3     3     2  
NOT COMPLETED     0     0     2  
Adverse Event                 0                 0                 2  



  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
Cytoreductive Nephrectomy Day 0 Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
Sorafenib + Cytoreductive Nephrectomy Day 8 Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
Sorafenib + Cytoreductive Nephrectomy Day 29 Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
Total Total of all reporting groups

Baseline Measures
    Cytoreductive Nephrectomy Day 0     Sorafenib + Cytoreductive Nephrectomy Day 8     Sorafenib + Cytoreductive Nephrectomy Day 29     Total  
Number of Participants  
[units: participants]
  3     3     4     10  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     1     1     2     4  
>=65 years     2     2     2     6  
Gender  
[units: participants]
       
Female     3     1     1     5  
Male     0     2     3     5  
Region of Enrollment  
[units: participants]
       
United States     3     3     4     10  



  Outcome Measures

1.  Primary:   Efficacy of BAY 43-9006 by Evaluating Response Rate   [ Time Frame: Every 2 weeks during 4 week cycle ]

2.  Secondary:   Time to Progression   [ Time Frame: Following 10 weeks of treatment or until disease progression ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Duration of Overall Response   [ Time Frame: Following 10 weeks of treatment, followed every 2 weeks or until disease progression ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Overall Survival   [ Time Frame: Up to 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eric Jonasch, MD / Associate Professor
Organization: UT MD Anderson Cancer Center
e-mail: caperez@mdanderson.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126659     History of Changes
Other Study ID Numbers: NCI-2012-02920, NCI-2012-02920, CDR0000438709, 2004-0516, 6630, P30CA016672, N01CM62202
Study First Received: August 2, 2005
Results First Received: September 28, 2012
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration