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Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511992
First Posted: August 6, 2007
Last Update Posted: July 2, 2017
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):
University of Oklahoma
Results First Submitted: April 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Advanced Ovarian Carcinoma
Primary Peritoneal Carcinoma
Ovarian Carcinosarcoma
Interventions: Drug: Avastin
Drug: Paclitaxel
Drug: Cisplatin

  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
Avastin

Avastin: Initial Treatment:

Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)

Consolidation Treatment:

Avastin 15mg/kg IV every 21 days x 12 cycles


Participant Flow:   Overall Study
    Avastin
STARTED   20 
COMPLETED   13 
NOT COMPLETED   7 



  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
Avastin

Avastin: Initial Treatment:

Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)

Consolidation Treatment:

Avastin 15mg/kg IV every 21 days x 12 cycles


Baseline Measures
   Avastin 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  70.0% 
>=65 years      6  30.0% 
Age 
[Units: Years]
Mean (Full Range)
 59 
 (45 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20 100.0% 
Male      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      3  15.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      16  80.0% 
More than one race      0   0.0% 
Unknown or Not Reported      1   5.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Able to Complete 6 Cycles of Treatment.   [ Time Frame: 2 years ]

2.  Secondary:   Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.   [ 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: Ingrid Block, CTO Director
Organization: University of Oklahoma
phone: 405 271-8001
e-mail: ingrid-block@ouhsc.edu



Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00511992     History of Changes
Other Study ID Numbers: 2674
First Submitted: August 3, 2007
First Posted: August 6, 2007
Results First Submitted: April 14, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017