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Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00301964
First Posted: March 13, 2006
Last Update Posted: December 5, 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: November 19, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
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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) 
Overall Participants Analyzed 
[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 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      52 100.0% 
Male      0   0.0% 
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:   To Determine the Nature and Degree of Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.   [ Time Frame: Up to 5 years ]

4.  Secondary:   Progression-free Survival   [ Time Frame: Every other cycle for the first 6 months; then every 4 cycles until progression or death, up to 5 years. ]

5.  Secondary:   Overall Survival   [ Time Frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. ]

6.  Secondary:   Initial Performance Status   [ Time Frame: Baseline ]

7.  Secondary:   Histologic Grade   [ Time Frame: Baseline ]


  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 ( U.S. NIH Grant/Contract )
First Submitted: March 9, 2006
First Posted: March 13, 2006
Results First Submitted: November 19, 2014
Results First Posted: November 26, 2014
Last Update Posted: December 5, 2017