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Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278343
First received: January 16, 2006
Last updated: May 31, 2017
Last verified: May 2017
Results First Received: September 23, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
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
No text entered.

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
Treatment (Cediranib Maleate)

Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.

cediranib maleate: Given PO

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Cediranib Maleate)
STARTED   74 
COMPLETED   74 
NOT COMPLETED   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.
Platinum sensitive: 39 Platinum resistant: 35 Total # treated: 74

Reporting Groups
  Description
Treatment (Cediranib Maleate)

Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.

cediranib maleate: Given PO

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Treatment (Cediranib Maleate) 
Overall Participants Analyzed 
[Units: Participants]
 74 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      55  74.3% 
>=65 years      19  25.7% 
Age 
[Units: Years]
Median (Full Range)
 58 
 (31 to 87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      74 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
Canada   52 
United States   22 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria   [ Time Frame: After 16 weeks ]

2.  Secondary:   Overall Survival (OS) (Discontinued as of 4/25/2014)   [ Time Frame: From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months. ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Time from start of treatment to time of progression, assessed up to 6 months ]

4.  Secondary:   Duration of Overall CA-125 Response   [ Time Frame: Up to 4 years ]

5.  Secondary:   Time to Disease Progression   [ Time Frame: Up to 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0   [ Time Frame: Up to 4 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
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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: Dr. Hal Hirte
Organization: Juarvinski Cancer Centre
phone: 905-387-9495
e-mail: hirteh@hhsc.ca


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00278343     History of Changes
Other Study ID Numbers: NCI-2012-03027
NCI-2012-03027 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-7129
PMH-PHL-037
PHL-037 ( Other Identifier: Princess Margaret Hospital Phase 2 Consortium )
7129 ( Other Identifier: CTEP )
N01CM62209 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62203 ( U.S. NIH Grant/Contract )
Study First Received: January 16, 2006
Results First Received: September 23, 2015
Last Updated: May 31, 2017