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Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Celgene Corporation
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00407563
First received: December 4, 2006
Last updated: March 8, 2012
Last verified: March 2012
Results First Received: September 28, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Interventions: Drug: Bevacizumab
Drug: Abraxane

  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
9 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in January 2007 and was completed in December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.

Reporting Groups
  Description
Bevacizumab and Abraxane All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.

Participant Flow:   Overall Study
    Bevacizumab and Abraxane  
STARTED     48  
COMPLETED     47 [1]
NOT COMPLETED     1  
Patient continues on treatment                 1  
[1] One patient remains on study treatment.



  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
Bevacizumab and Abraxane All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.

Baseline Measures
    Bevacizumab and Abraxane  
Number of Participants  
[units: participants]
  48  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     26  
>=65 years     22  
Age  
[units: years]
Mean ± Standard Deviation
  61.6  ± 10.22  
Gender  
[units: participants]
 
Female     48  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     48  



  Outcome Measures
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1.  Primary:   6-month Progression-Free Rate   [ Time Frame: 6 months after initiation of study treatment ]

2.  Secondary:   Best Overall Response   [ Time Frame: Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months. ]

3.  Secondary:   Overall Survival   [ Time Frame: Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months. ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months. ]

5.  Secondary:   Best Overall Response at Six Months   [ Time Frame: Assessed over 6 months of study treatment ]


  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:  
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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Vice President of Scientific Affairs
Organization: Accelerated Community Oncology Research Network, Inc.
phone: 901-435-5570
e-mail: mwalker@acorncro.com


No publications provided by Accelerated Community Oncology Research Network

Publications automatically indexed to this study:

Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00407563     History of Changes
Other Study ID Numbers: ACORN ALSSOPR0501
Study First Received: December 4, 2006
Results First Received: September 28, 2011
Last Updated: March 8, 2012
Health Authority: United States: Institutional Review Board