Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00072176
First received: November 4, 2003
Last updated: February 5, 2015
Last verified: March 2014
Results First Received: February 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Endometrial Adenocarcinoma
Endometrial Adenosquamous Cell Carcinoma
Endometrial Clear Cell Carcinoma
Endometrial Papillary Serous Carcinoma
Recurrent Endometrial Carcinoma
Stage IIIA Endometrial Carcinoma
Stage IIIB Endometrial Carcinoma
Stage IIIC Endometrial Carcinoma
Stage IVA Endometrial Carcinoma
Stage IVB Endometrial Carcinoma
Interventions: Drug: temsirolimus
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
Patients were recruited from 10 participating centers across Canada between May 2004 and June 2007.

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
Group A

Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

temsirolimus: Given IV

laboratory biomarker analysis: Correlative studies

Group B

Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

temsirolimus: Given IV

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Group A     Group B  
STARTED     34     28  
COMPLETED     33     27  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 0  
Protocol Violation                 0                 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.
All patients received treatment

Reporting Groups
  Description
Group A

Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

temsirolimus: Given IV

laboratory biomarker analysis: Correlative studies

Group B

Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

temsirolimus: Given IV

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Group A     Group B     Total  
Number of Participants  
[units: participants]
  33     27     60  
Age  
[units: years]
Median (Full Range)
  66  
  (52 to 80)  
  60  
  (41 to 81)  
  63  
  (41 to 81)  
Gender  
[units: participants]
     
Female     33     27     60  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Canada     33     27     60  



  Outcome Measures
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1.  Primary:   Objective Clinical Response Rate   [ Time Frame: Up to 5 years ]

2.  Primary:   Progression-free Survival (Tumor Progression)   [ Time Frame: 5 years ]


  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: Dr. Amit M. Oza
Organization: Princess Margaret Hospital, Toronto, Canada
phone: 416 946 4501 ext 2818
e-mail: amit.oza@uhn.ca



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072176     History of Changes
Other Study ID Numbers: NCI-2014-00649
NCI-2014-00649 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I160
CAN-NCIC-IND160
IND.160
CDR0000335543
NCIC-160 ( Other Identifier: National Cancer Institute of Canada Clinical Trials Group )
NCIC-160 ( Other Identifier: CTEP )
Study First Received: November 4, 2003
Results First Received: February 5, 2015
Last Updated: February 5, 2015
Health Authority: United States: Food and Drug Administration