Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00887809
First received: April 23, 2009
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: December 21, 2015  
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 Fibrous
Histiocytoma
Angiosarcoma
Interventions: Drug: gemcitabine
Drug: docetaxel
Drug: bevacizumab

  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
Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Bevacizumab
Gemcitabine, Docetaxel, Placebo Gemcitabine, Docetaxel, Placebo

Participant Flow:   Overall Study
    Gemcitabine, Docetaxel, Bevacizumab     Gemcitabine, Docetaxel, Placebo  
STARTED     37     10  
COMPLETED     33     10  
NOT COMPLETED     4     0  
Patient Not Treated                 3                 0  
Death                 1                 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.
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Reporting Groups
  Description
Gemcitabine, Docetaxel, Bevacizumab Gemcitabine, Docetaxel, Bevacizumab
Gemcitabine, Docetaxel, Placebo Gemcitabine, Docetaxel, Placebo
Total Total of all reporting groups

Baseline Measures
    Gemcitabine, Docetaxel, Bevacizumab     Gemcitabine, Docetaxel, Placebo     Total  
Number of Participants  
[units: participants]
  37     10     47  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     26     7     33  
>=65 years     11     3     14  
Gender  
[units: participants]
     
Female     22     2     24  
Male     15     8     23  



  Outcome Measures

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


  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: NCT00887809     History of Changes
Other Study ID Numbers: 09-015
Study First Received: April 23, 2009
Results First Received: December 21, 2015
Last Updated: December 21, 2015
Health Authority: United States: Institutional Review Board