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Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588237
First Posted: January 8, 2008
Last Update Posted: January 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: December 15, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Primary PERITONEUM
Fallopian Tube Cancer
Intervention: Drug: Paclitaxel,Cisplatin, 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
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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
All Patients Paclitaxel, Cisplatin, Bevacizumab

Participant Flow:   Overall Study
    All Patients
STARTED   42 
COMPLETED   38 
NOT COMPLETED   4 
Evaluable for toxicity only                3 
Patien not treated                1 



  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
All Patients Paclitaxel, Cisplatin, Bevacizumab

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   40 
>=65 years   2 
Gender 
[Units: Participants]
 
Female   42 
Male   0 


  Outcome Measures

1.  Primary:   Overall Objective Response   [ Time Frame: 2 years ]


  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. Jason Konner
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4219
e-mail: konnerj@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588237     History of Changes
Other Study ID Numbers: 06-064
First Submitted: December 22, 2007
First Posted: January 8, 2008
Results First Submitted: December 15, 2015
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016