Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)

This study has been completed.
Sponsor:
Collaborator:
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Richard Thomas Penson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00129727
First received: August 10, 2005
Last updated: April 24, 2016
Last verified: April 2016
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: Paclitaxel
Drug: Carboplatin
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
Recruitment occurred during the planned time frame. Recruitment occurred at Massachusetts General Hospital; Dana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; and Women and Infants Hospital of Rhode Island.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phase II of Carboplatin, Pacitaxel, and Bevacizumab Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.

Participant Flow:   Overall Study
    Phase II of Carboplatin, Pacitaxel, and Bevacizumab  
STARTED     62  
COMPLETED     57  
NOT COMPLETED     5  



  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
Phase II of Carboplatin, Pacitaxel, and Bevacizumab Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.

Baseline Measures
    Phase II of Carboplatin, Pacitaxel, and Bevacizumab  
Number of Participants  
[units: participants]
  62  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     44  
>=65 years     17  
Age  
[units: years]
Mean (Standard Deviation)
  57  (12)  
Gender  
[units: participants]
 
Female     62  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     62  



  Outcome Measures
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1.  Primary:   PFS   [ Time Frame: Median PFS in months - up to 5 years ]

2.  Secondary:   Response Rate (RECIST-1)   [ Time Frame: 5 years ]

3.  Secondary:   Toxicity   [ Time Frame: 60 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
Phase II uncontrolled trial


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard T Penson MD MRCP
Organization: Massachusetts General Hospital
phone: 617-726-5867
e-mail: rpenson@partners.org



Responsible Party: Richard Thomas Penson, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00129727     History of Changes
Other Study ID Numbers: 04-247
Study First Received: August 10, 2005
Results First Received: July 20, 2011
Last Updated: April 24, 2016
Health Authority: United States: Food and Drug Administration