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Trial record 2 of 6 for:    "Carcinoid Syndrome" | "Miconazole"

Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma

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ClinicalTrials.gov Identifier: NCT00093782
Recruitment Status : Completed
First Posted : October 8, 2004
Results First Posted : December 12, 2016
Last Update Posted : February 7, 2017
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 Metastatic Gastrointestinal Carcinoid Tumor
Pulmonary Carcinoid Tumor
Recurrent Gastrointestinal Carcinoid Tumor
Recurrent Islet Cell Carcinoma
Interventions Drug: temsirolimus
Other: laboratory biomarker analysis
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Temsirolimus)
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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

Period Title: Overall Study
Started 36
Completed 36
Not Completed 0
Arm/Group Title Treatment (Temsirolimus)
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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

Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
Number of participants accrued
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  77.8%
>=65 years
8
  22.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants
58
(36 to 78)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
21
  58.3%
Male
15
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 36 participants
36
1.Primary Outcome
Title Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Temsirolimus)
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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

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Stable Disease Rate Defined by RECIST Criteria
Hide Description Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
Time Frame Up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
20
3.Secondary Outcome
Title Median Survival Time
Hide Description Computed using the Kaplan-Meier method.
Time Frame 3
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Out of the 25 patients alive (in 2006 at time of publication)
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
13.9
(2.8 to 22.6)
4.Secondary Outcome
Title Survival Rate
Hide Description Computed using the Kaplan-Meier method.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 25 patients alive as of Jan 2006
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71.5
(57.1 to 89.5)
5.Secondary Outcome
Title Response and Stable Disease
Hide Description Assessed using RECIST criteria.Patients that had Stable disease for 2 months
Time Frame 2 months
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Hide Analysis Population Description
Number of patients that had stable disease for 2 months
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: patients
20
6.Secondary Outcome
Title Number of Temsirolimus Treatment Cycle Analyzed for Toxicity
Hide Description Safety and tolerability of treatment with Temsirolimus assessed using CTCAE v 3
Time Frame Duration of participants treatment upto 16wks (4cycles) of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: treatment cycles
213
7.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame Up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of publication, 5 patients were still on treatment and analysis was done on 31 patients
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 31
Median (95% Confidence Interval)
Unit of Measure: months
6.0 [1] 
(3.7 to NA)
[1]
Not reached
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Temsirolimus)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Temsirolimus)
Affected / at Risk (%)
Total   1/36 (2.78%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax   1/36 (2.78%) 
Vascular disorders   
Thromboembolic event   1/36 (2.78%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Temsirolimus)
Affected / at Risk (%)
Total   28/36 (77.78%) 
General disorders   
Fatigue   28/36 (77.78%) 
Metabolism and nutrition disorders   
Hyperglycemia   25/36 (69.44%) 
Skin and subcutaneous tissue disorders   
rash / desquamation   23/36 (63.89%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lillian Siu
Organization: Princess Margaret Cancer Centre
Phone: 416-946-2911
EMail: lillian.siu@uhn.ca
Layout table for additonal information
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 )
First Submitted: October 6, 2004
First Posted: October 8, 2004
Results First Submitted: June 11, 2015
Results First Posted: December 12, 2016
Last Update Posted: February 7, 2017