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Bevacizumab With or Without Fosbretabulin Tromethamine in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305213
First Posted: February 28, 2011
Last Update Posted: July 12, 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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: June 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions: Biological: Bevacizumab
Drug: Fosbretabulin Tromethamine
Other: Laboratory Biomarker Analysis

  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
The study was activated on 3/21/2011 and closed on 4/22/2013

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
Arm I Bevacizumab Bevacizumab 15mg/kg IV Day 1 every 3 weeks
Arm II Bevacizumab + Fosbretabulin Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks

Participant Flow:   Overall Study
    Arm I Bevacizumab   Arm II Bevacizumab + Fosbretabulin
STARTED   53   54 
COMPLETED   53   54 
NOT COMPLETED   0   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.
No text entered.

Reporting Groups
  Description
Arm I Bevacizumab Bevacizumab 15mg/kg IV Day 1 every 3 weeks
Arm II Bevacizumab + Fosbretabulin Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
Total Total of all reporting groups

Baseline Measures
   Arm I Bevacizumab   Arm II Bevacizumab + Fosbretabulin   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   54   107 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (12)   64.9  (10.3)   64.6  (11.15) 
Age, Customized 
[Units: Participants]
Count of Participants
     
30 - 39 years   2   0   2 
40 - 49 years   3   5   8 
50 - 59 years   12   12   24 
60 - 69 years   19   15   34 
70 - 79 years   13   19   32 
> = 80 years   4   3   7 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      53 100.0%      54 100.0%      107 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years ]

2.  Secondary:   Tumor Response   [ Time Frame: for those patients whose disease can be evaluated by physical examination, response wa assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years ]

3.  Secondary:   Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Measurable Disease by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria and Progression Free Survival (PFS)   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Response by CA-125   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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 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.
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: Linda Gedeon for Michael Sill, PhD
Organization: NRG Oncology
phone: 716-845-1169
e-mail: lgedeon@gogstats.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01305213     History of Changes
Other Study ID Numbers: NCI-2011-02666
NCI-2011-02666 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000696220
GOG-0186I ( Other Identifier: NRG Oncology )
GOG-0186I ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: February 25, 2011
First Posted: February 28, 2011
Results First Submitted: June 14, 2017
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017