Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    "Uterine Carcinosarcoma" | "Miconazole"
Previous Study | Return to List | Next Study

Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus

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: NCT01061606
Recruitment Status : Terminated (Poor accrual)
First Posted : February 3, 2010
Results First Posted : November 9, 2016
Last Update Posted : November 9, 2016
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 Recurrent Uterine Sarcoma
Uterine Carcinosarcoma
Intervention Drug: temsirolimus
Enrollment 8
Recruitment Details A total of 8 patients were enrolled at two institutions between July 2010 and January 2012
Pre-assignment Details  
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 8
Completed 0
Not Completed 8
Reason Not Completed
Adverse Event             1
Death             1
Disease Progression             4
alternative therapy             2
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
62
(47 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
8
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants
White 3
Black 2
Unknown 3
1.Primary Outcome
Title Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
Hide Description [Not Specified]
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Disease progression 4
Stable disease 2
2.Primary Outcome
Title Progression Free Survival
Hide Description The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.
Time Frame 6 months from registration
Hide Outcome Measure Data
Hide Analysis Population Description
The study concluded terminated early and patients were not followed.
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description Time to event distributions will be estimated using the Kaplan-Meier method.
Time Frame From registration to death, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study concluded terminated early and patients were not followed.
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient’s Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented
Hide Description Median duration of response and the confidence interval for the median duration will be computed.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study concluded terminated early and patients were not followed.
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure will be evaluated using the method of Kaplan-Meier.
Time Frame From study registration to the date patients end treatment, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study concluded terminated early and patients were not followed.
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame Time to progression is defined as the time from registration to disease progression.
Hide Outcome Measure Data
Hide Analysis Population Description
The study concluded terminated early and patients were not followed.
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Temsirolimus)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Temsirolimus)
Affected / at Risk (%) # Events
Total   5/8 (62.50%)    
Gastrointestinal disorders   
Ascites  1/8 (12.50%)  1
Constipation  2/8 (25.00%)  2
Abdominal pain  3/8 (37.50%)  3
Nausea  2/8 (25.00%)  2
Vomiting  1/8 (12.50%)  1
General disorders   
Death NOS  1/8 (12.50%)  1
Fatigue  1/8 (12.50%)  1
Infections and infestations   
Urinary Tract infection  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1/8 (12.50%)  1
Dyspnea  1/8 (12.50%)  1
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 (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Anemia  3/8 (37.50%)  3
Ear and labyrinth disorders   
Tinnitus  1/8 (12.50%)  1
Ear pain  1/8 (12.50%)  1
Eye disorders   
Left eye twitching  1/8 (12.50%)  1
Gastrointestinal disorders   
Diarrhea  3/8 (37.50%)  3
Anorexia  2/8 (25.00%)  2
Mucositis: oral  1/8 (12.50%)  1
Flatulence  1/8 (12.50%)  1
Abdominal distension  1/8 (12.50%)  1
Epigastric pain  1/8 (12.50%)  1
General disorders   
Edema limbs  1/8 (12.50%)  1
Chills  2/8 (25.00%)  2
Non-cardiac chest pain  1/8 (12.50%)  1
Investigations   
Alanine aminotransferase increased  1/8 (12.50%)  1
Cholesterol high  1/8 (12.50%)  1
Alkaline phosphatase increased  1/8 (12.50%)  1
Metabolism and nutrition disorders   
Hypertriglyceridemia  1/8 (12.50%)  1
Hyperglycemia  2/8 (25.00%)  2
Musculoskeletal and connective tissue disorders   
Myalgia  2/8 (25.00%)  2
Arthralgia  1/8 (12.50%)  1
Shoulder pain  1/8 (12.50%)  1
Knee pain  1/8 (12.50%)  1
Nervous system disorders   
Dysgeusia  2/8 (25.00%)  2
Dizziness  1/8 (12.50%)  1
Headache  1/8 (12.50%)  1
Peripheral sensory neuropathy  1/8 (12.50%)  1
Depression  1/8 (12.50%)  1
Psychiatric disorders   
Insomnia  2/8 (25.00%)  2
Euphoria  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic Rhinitis  1/8 (12.50%)  1
Cough  1/8 (12.50%)  1
Epistaxis  1/8 (12.50%)  1
Sore throat  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Rasch: acneiform  1/8 (12.50%)  1
Dry skin  1/8 (12.50%)  1
Nail discoloration  1/8 (12.50%)  1
Nail changes  1/8 (12.50%)  1
Pruritis  2/8 (25.00%)  2
Vascular disorders   
Hot flashes  1/8 (12.50%)  1
Hypertension  2/8 (25.00%)  2
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: Lisa Escobar-Peralta, Program Manager
Organization: Montefiore Medical Center
Phone: 718-379-6866
EMail: lescobar@montefiore.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01061606     History of Changes
Other Study ID Numbers: NCI-2012-02989
NCI-2012-02989 ( Other Identifier: CTRP (Clinical Trial Reporting Program) )
8167 ( Other Identifier: CTEP )
N01CM00038 ( U.S. NIH Grant/Contract )
P30CA013330 ( U.S. NIH Grant/Contract )
First Submitted: February 2, 2010
First Posted: February 3, 2010
Results First Submitted: September 21, 2016
Results First Posted: November 9, 2016
Last Update Posted: November 9, 2016