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Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093782
First received: October 6, 2004
Last updated: December 14, 2016
Last verified: December 2016
Results First Received: June 11, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Metastatic Gastrointestinal Carcinoid Tumor
Pulmonary Carcinoid Tumor
Recurrent Gastrointestinal Carcinoid Tumor
Recurrent Islet Cell Carcinoma
Interventions: Drug: temsirolimus
Other: laboratory biomarker analysis

  Participant Flow
  Hide 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 CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.

temsirolimus: Given IV

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Temsirolimus)
STARTED   36 
COMPLETED   36 
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.
Number of participants accrued

Reporting Groups
  Description
Treatment (Temsirolimus)

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.

temsirolimus: Given IV

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Treatment (Temsirolimus) 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      28  77.8% 
>=65 years      8  22.2% 
Age 
[Units: Years]
Median (Full Range)
 58 
 (36 to 78) 
Gender 
[Units: Participants]
Count of Participants
 
Female      21  58.3% 
Male      15  41.7% 
Region of Enrollment 
[Units: Participants]
 
Canada   36 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)   [ Time Frame: Up to 8 years ]

2.  Secondary:   Stable Disease Rate Defined by RECIST Criteria   [ Time Frame: Up to 8 years ]

3.  Secondary:   Median Survival Time   [ Time Frame: 3 ]

4.  Secondary:   Survival Rate   [ Time Frame: 1 year ]

5.  Secondary:   Response and Stable Disease   [ Time Frame: 2 months ]

6.  Secondary:   Number of Temsirolimus Treatment Cycle Analyzed for Toxicity   [ Time Frame: Duration of participants treatment upto 16wks (4cycles) of treatment ]

7.  Secondary:   Time to Progression   [ Time Frame: Up to 8 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
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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. Lillian Siu
Organization: Princess Margaret Cancer Centre
phone: 416-946-2911
e-mail: lillian.siu@uhn.ca



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093782     History of Changes
Other Study ID Numbers: NCI-2012-03053
PHL-021
6171
N01CM17105 ( U.S. NIH Grant/Contract )
N01CM17107 ( U.S. NIH Grant/Contract )
N01CM17102 ( U.S. NIH Grant/Contract )
Study First Received: October 6, 2004
Results First Received: June 11, 2015
Last Updated: December 14, 2016