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Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma

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ClinicalTrials.gov Identifier: NCT00245102
Recruitment Status : Completed
First Posted : October 27, 2005
Results First Posted : January 20, 2014
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Angiosarcoma
Adult Epithelioid Sarcoma
Adult Leiomyosarcoma
Adult Malignant Fibrous Histiocytoma
Adult Neurofibrosarcoma
Adult Synovial Sarcoma
Ovarian Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Uterine Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage III Uterine Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Uterine Sarcoma
Uterine Carcinosarcoma
Uterine Leiomyosarcoma
Intervention: Drug: sorafenib tosylate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol Open to Accrual 09/09/2005 Protocol Closed to Accrual 07/22/2008 Primary Completion Date 03/22/2011 Recruitment Location is the medical clinic

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
Angiosarcoma Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MPNST Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Leiomyosarcoma Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Undifferentiated Pleomorphic Sarcoma Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Fibrosarcoma Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Histology Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Angiosarcoma   MPNST   Leiomyosarcoma   Undifferentiated Pleomorphic Sarcoma   Fibrosarcoma   Other Histology
STARTED   44   16   46   13   5   23 
COMPLETED   37   12   39   10   5   19 
NOT COMPLETED   7   4   7   3   0   4 
Not Treated                1                0                1                0                0                0 
Protocol Violation                1                0                0                0                0                0 
Death                0                0                0                1                0                0 
Adverse Event                4                2                5                1                0                2 
Decline in performance                0                2                0                1                0                2 
Participant needed surgery                0                0                1                0                0                0 
Clinical progression                1                0                0                0                0                0 



  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
Angiosarcoma Sorafenib 400 mg PO BID
MPNST Sorafenib 400 mg PO BID
Leiomyosarcoma Sorafenib 400 mg PO BID
Undifferentiated Pleomorphic Sarcoma Sorafenib 400 mg PO BID
Fibrosarcoma Sorafenib 400 mg PO BID
Other Histology Sorafenib 400 mg PO BID
Total Total of all reporting groups

Baseline Measures
   Angiosarcoma   MPNST   Leiomyosarcoma   Undifferentiated Pleomorphic Sarcoma   Fibrosarcoma   Other Histology   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   16   46   13   5   23   147 
Age 
[Units: Participants]
             
<=18 years   0   0   0   0   0   0   0 
Between 18 and 65 years   20   14   35   7   5   22   103 
>=65 years   24   2   11   6   0   1   44 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (50.91168825)   47.5  (34.64823228)   56  (33.9411255)   62.5  (31.81980515)   43.5  (10.60660172)   44  (31.11269837)   54  (50.91168825) 
Gender 
[Units: Participants]
             
Female   25   9   37   8   4   11   94 
Male   19   7   9   5   1   12   53 
Region of Enrollment 
[Units: Participants]
             
United States   44   15   46   13   5   23   146 
Italy   0   1   0   0   0   0   1 


  Outcome Measures

1.  Primary:   Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST   [ Time Frame: Up to 4 weeks ]


  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:  
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: Dr. William Tap
Organization: Memorial Sloan-Kettering Cancer Center
phone: 646-888-4163
e-mail: tapw@mskcc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00245102     History of Changes
Other Study ID Numbers: NCI-2012-01469
NCI-2012-01469 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-7060
CDR0000449962
MSKCC-05081
05-081 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
7060 ( Other Identifier: CTEP )
N01CM62206 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
First Submitted: October 25, 2005
First Posted: October 27, 2005
Results First Submitted: November 19, 2013
Results First Posted: January 20, 2014
Last Update Posted: May 23, 2014