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Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)

This study has been terminated.
(Lack of accrual)
Sponsor:
Collaborators:
National Comprehensive Cancer Network
University of California, Los Angeles
Washington University School of Medicine
Northwestern University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01418001
First received: August 15, 2011
Last updated: January 19, 2016
Last verified: January 2016
Results First Received: January 19, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Sarcoma
Leiomyosarcoma
Malignant Peripheral Nerve Sheath Tumor
Malignant Fibrous
Histiocytoma/Undifferentiated Pleomorphic Sarcoma
Intervention: Drug: Gemcitabine and Docetaxel in Combination with Pazopanib

  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
No text entered.

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
Level 1: Pazopanib 400 mg QD Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib

Participant Flow:   Overall Study
    Level 1: Pazopanib 400 mg QD  
STARTED     5  
COMPLETED     5  
NOT COMPLETED     0  



  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
Level 1: Pazopanib 400 mg QD Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib

Baseline Measures
    Level 1: Pazopanib 400 mg QD  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     4  
Gender  
[units: participants]
 
Female     1  
Male     4  



  Outcome Measures

1.  Primary:   Overall Objective Response   [ Time Frame: Every 6 weeks ]

2.  Secondary:   Pathologic Response   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting 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
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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. William Tap
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4163
e-mail: tapw@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01418001     History of Changes
Other Study ID Numbers: 11-104
Study First Received: August 15, 2011
Results First Received: January 19, 2016
Last Updated: January 19, 2016
Health Authority: United States: Food and Drug Administration