Trial Outcomes & Findings for Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus (NCT NCT01061606)
NCT ID: NCT01061606
Last Updated: 2016-11-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2016-11-09
Participant Flow
A total of 8 patients were enrolled at two institutions between July 2010 and January 2012
Participant milestones
| Measure |
Treatment (Temsirolimus)
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 Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Treatment (Temsirolimus)
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 Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease Progression
|
4
|
|
Overall Study
alternative therapy
|
2
|
Baseline Characteristics
Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Baseline characteristics by cohort
| Measure |
Treatment (Temsirolimus)
n=8 Participants
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
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
Treatment (Temsirolimus)
n=6 Participants
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
|
|---|---|
|
Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
Disease progression
|
4 participants
|
|
Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
Stable disease
|
2 participants
|
PRIMARY outcome
Timeframe: 6 months from registrationPopulation: The study concluded terminated early and patients were not followed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From registration to death, assessed up to 3 yearsPopulation: The study concluded terminated early and patients were not followed.
Time to event distributions will be estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The study concluded terminated early and patients were not followed.
Median duration of response and the confidence interval for the median duration will be computed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study registration to the date patients end treatment, assessed up to 3 yearsPopulation: The study concluded terminated early and patients were not followed.
Time to treatment failure will be evaluated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time to progression is defined as the time from registration to disease progression.Population: The study concluded terminated early and patients were not followed.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Temsirolimus)
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Temsirolimus)
n=8 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2
|
|
Infections and infestations
Urinary Tract infection
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
37.5%
3/8 • Number of events 3
|
|
General disorders
Death NOS
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Temsirolimus)
n=8 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
3/8 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
25.0%
2/8 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
12.5%
1/8 • Number of events 1
|
|
Eye disorders
Left eye twitching
|
12.5%
1/8 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rasch: acneiform
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • Number of events 3
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
2/8 • Number of events 2
|
|
Investigations
Cholesterol high
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis: oral
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Depression
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • Number of events 2
|
|
Psychiatric disorders
Euphoria
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Chills
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
2/8 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
12.5%
1/8 • Number of events 1
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Epigastric pain
|
12.5%
1/8 • Number of events 1
|
Additional Information
Lisa Escobar-Peralta, Program Manager
Montefiore Medical Center
Phone: 718-379-6866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60