Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00301964
First received: March 9, 2006
Last updated: November 19, 2014
Last verified: October 2013
Results First Received: November 19, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Recurrent Endometrial Carcinoma
Interventions: Biological: bevacizumab
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
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
Treatment (Bevacizumab)

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Bevacizumab)  
STARTED     56  
COMPLETED     52 [1]
NOT COMPLETED     4  
Second primary                 2  
Wrong primary                 1  
Inadequate pathology                 1  
[1] Total number of eligible and evaluable participants



  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.
Total number of eligible and evaluable participants

Reporting Groups
  Description
Treatment (Bevacizumab)

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Treatment (Bevacizumab)  
Number of Participants  
[units: participants]
  52  
Age  
[units: years]
Mean (Standard Deviation)
  62.3  (10.3)  
Age, Customized  
[units: participants]
 
30-39 years     1  
40-49 years     4  
50-59 years     13  
60-69 years     22  
70-79 years     11  
80-89 years     1  
Gender  
[units: participants]
 
Female     52  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     52  
Cell Type  
[units: participants]
 
Adenocarcinoma, Unspecified     1  
Clear Cell Carcinoma     4  
Endometrioid Adenocarcinoma     26  
Mucinous Adenocarcinoma     1  
Mixed Epithelial Carcinoma     5  
Undifferentiated Carcinoma     1  
Serous Adenocarcinoma     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival Greater Than 6 Months   [ Time Frame: 6 months ]

2.  Primary:   Best Tumor Response   [ Time Frame: study entry through completion ]

3.  Primary:   Frequency of Adverse Effects   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Primary:   Severity of Adverse Events as Assessed by CTCAE Version 3.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Progression-free Survival   [ Time Frame: From study entry until disease progression, death or date of last contact, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Overall Survival   [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Initial Performance Status and Histological Grade   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 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: Jessalyn Reboy
Organization: NRG Oncology, Statistics and Data Management Center, Buffalo Office
phone: 716-845-7738
e-mail: ReboyJ@nrgoncology.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00301964     History of Changes
Other Study ID Numbers: NCI-2012-02692
NCI-2012-02692 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000465502
GOG-0229E ( Other Identifier: Gynecologic Oncology Group )
GOG-0229E ( Other Identifier: CTEP )
U10CA027469 ( US NIH Grant/Contract Award Number )
Study First Received: March 9, 2006
Results First Received: November 19, 2014
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration