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Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed By Surgery

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.
ClinicalTrials.gov Identifier: NCT01026792
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : September 10, 2015
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Carcinoma
Stage IIIA Cervical Cancer
Stage IIIB Cervical Cancer
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Interventions: Drug: Temsirolimus
Other: Laboratory Biomarker Analysis

  Participant Flow

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 (Temsirolimus) Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Temsirolimus)
STARTED   38 
COMPLETED   37 
NOT COMPLETED   1 
Protocol Violation                1 



  Baseline Characteristics

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 eligible patients

Reporting Groups
  Description
Treatment (Temsirolimus) Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Treatment (Temsirolimus) 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Years]
Median (Full Range)
 50 
 (26 to 77) 
Gender 
[Units: Participants]
 
Female   37 
Male   0 


  Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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. Anna Tinker
Organization: BC Cancer Agency, Vancouver Clinic, Vancouver, BC, Canada
phone: 604 877 6217
e-mail: atinker@bccancer.bc.ca



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01026792     History of Changes
Other Study ID Numbers: NCI-2014-00268
NCI-2014-00268 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCIC-CTG-199
CDR0000660702
IND.199
CAN-NCIC-IND199
NCIC-199 ( Other Identifier: National Cancer Institute of Canada Clinical Trials Group )
NCIC-199 ( Other Identifier: CTEP )
First Submitted: December 3, 2009
First Posted: December 4, 2009
Results First Submitted: July 6, 2015
Results First Posted: September 10, 2015
Last Update Posted: September 10, 2015