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Cediranib Maleate in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01132820
First Posted: May 28, 2010
Last Update Posted: August 28, 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: December 15, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Endometrial Adenocarcinoma
Endometrial Adenosquamous Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Recurrent Uterine Corpus Carcinoma
Interventions: Drug: Cediranib Maleate
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 6/7/2010 and suspended to accrual on 3/7/2011. The study reopened on 11/21/2011 and closed on 4/30/2012.

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
Cediranib Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.

Participant Flow:   Overall Study
    Cediranib
STARTED   53 
COMPLETED   48 
NOT COMPLETED   5 
Ineligible: wrong cell type                1 
Ineligible:Improper pre-protocol therapy                1 
Ineligible:Inadequate pathology                1 
Never treated                1 
Inadequate data                1 



  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
Cediranib Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.

Baseline Measures
   Cediranib 
Overall Participants Analyzed 
[Units: Participants]
 48 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.9  (9.5) 
Age, Customized 
[Units: Participants]
Count of Participants
 
20-29 years   0 
30-39 years   0 
40-49 years   3 
50-59 years   10 
60-69 years   20 
70-79 years   12 
80-89 years   3 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      48 100.0% 
Male      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0   [ Time Frame: Up to 5 years ]

2.  Primary:   Tumor Response   [ Time Frame: For diesease evaluated by physical examination, response was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle from enrollment until stopping study therapy. The average time on study is 3 mnths ]

3.  Primary:   Progression-free Survival (PFS) = > 6 Months   [ Time Frame: For disease evaluated by physical examination, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. Evaluated from time of enrollment until progression or death, up to 5 years ]

4.  Secondary:   Overall Survival   [ Time Frame: From study entry to death or last contact, up to 5 years. ]

5.  Secondary:   Progression Free Survival   [ Time Frame: Disease that can be assessed by physical exam should be evaluated every cycle. disease assessed by imaging should be evaluated every other cycle. Time frame to determine the date of progression is from the date of enrollment up to 5 years after enrollment ]

6.  Secondary:   Response Without Regard to the Time of Documented Response   [ Time Frame: Tumor responses with time restriction starts at enrollment and goes to 6 months after enrollment or until pt. off study therapy,whichever occurs first. Without time restriction starts at enrollment,lasts until off study therapy, median duration = 2.63 mth ]

7.  Other Pre-specified:   Expression of Phosphorylated ERK1 and 2, c-Jun, Stat3, PKC, and p70S6 Kinase   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Levels of Receptor Targets Such as VEGFR (1, 2, 3) and PDGFR   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Plasma Levels of Endogenous Circulating VEGFA, Levels of Its Endogenous Inhibitor, sFlt-1 (the Truncated, Circulating Portion of VEGFR-1), Circulating TF, and Circulating Par-4   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   VEGFA Expression on Pre-treatment Tumor Specimens   [ Time Frame: Baseline ]
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
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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: Linda Gedeon for Michael Sill, PhD
Organization: NRG Oncology /GOG
phone: 716 845-1169
e-mail: lgedeon@gogstats.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01132820     History of Changes
Other Study ID Numbers: NCI-2011-02043
NCI-2011-02043 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0229J
CDR0000674008
GOG-0229J ( Other Identifier: NRG Oncology )
GOG-0229J ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: May 27, 2010
First Posted: May 28, 2010
Results First Submitted: December 15, 2016
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017