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S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00217620
First received: September 20, 2005
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
Results First Received: October 3, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sarcoma
Intervention: Drug: sorafenib

  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
Sorafenib (BAY 43-9006) Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.

Participant Flow:   Overall Study
    Sorafenib (BAY 43-9006)  
STARTED     51  
Eligible     38  
Eligible and Began Protocol Therapy     37  
COMPLETED     0  
NOT COMPLETED     51  
Adverse Event                 2  
Progression                 31  
Not Protocol Specified                 4  
Ineligible                 13  
Never received treatment                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Sorafenib (BAY 43-9006) Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.

Baseline Measures
    Sorafenib (BAY 43-9006)  
Number of Participants  
[units: participants]
 		  37  
Age  
[units: years]
Median ( Full Range ) 		  62.7  
  ( 24.0 to 88.5 )  
Gender  
[units: participants]
 		 
Female     22  
Male     15  
Race/Ethnicity, Customized  
[units: participants]
 		 
White     33  
Black     3  
Pacific Islander     1  
Histology  
[units: participants]
 		 
Leiomyosarcoma     19  
Liposarcoma     10  
Soft Tissue Sarcoma of Vascular Derivation     8  
Performance Status [1]
[units: participants]
 		 
0     15  
1     22  
[1] Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.



  Outcome Measures
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1.  Primary:   Objective Response (Confirmed, Complete and Partial)   [ Time Frame: Assessment performed every eight weeks until progression. ]
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2.  Secondary:   Four-month Progression-free Survival Rate   [ Time Frame: 0 - 4 months ]
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3.  Secondary:   Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration of protocol treatment. ]
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  Serious Adverse Events
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  Other Adverse Events
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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 NOT 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.


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
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Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


Publications of Results:
Ryan CW, von Mehren M, Rankin CJ, et al.: Phase II intergroup study of sorafenib (S) in advanced soft tissue arcomas (STS): SWOG 0505. [Abstract] J Clin Oncol 26 (Suppl 15): A-10532, 2008.


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00217620     History of Changes
Other Study ID Numbers: NCI-2012-03063, S0505, U10CA032102, CDR0000442404
Study First Received: September 20, 2005
Results First Received: October 3, 2012
Last Updated: January 4, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration