Trial Outcomes & Findings for Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT00429793)
NCT ID: NCT00429793
Last Updated: 2019-07-24
Results Overview
Number of participants who survived progression-free for more than 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
6 months
Results posted on
2019-07-24
Participant Flow
Patients were accrued to the first stage of accrual from 2/5/07 to 9/4/07. Patients were accrued to the second stage of accrual between 5/7/08 to 8/25/08. They received 25 mg IV of CCI-779 weekly. One cycle was 28 days.
Patients were required to have had one regimen of a platinum agent for the treatment of ovarian cancer. Patients entering the study therefore were required to have either persistent or recurrent cancer that was measurable by RECIST.
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.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
6
|
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.
|
|---|---|
|
Overall Study
Improper pre-protocol treatment
|
3
|
|
Overall Study
Required test not done
|
1
|
|
Overall Study
Never treated
|
1
|
|
Overall Study
Non-measurable
|
1
|
Baseline Characteristics
Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Age, Customized
20-29 years
|
2 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
7 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
15 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
11 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
16 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Recurrent/Persistent Disease
|
54 participants
n=5 Participants
|
|
Cell Type
Adenocarcinoma, unspecified
|
8 participants
n=5 Participants
|
|
Cell Type
Clear Cell Carcinoma
|
3 participants
n=5 Participants
|
|
Cell Type
Endometrioid Adenocarcinoma
|
4 participants
n=5 Participants
|
|
Cell Type
Serous Adenocarcinoma
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants who survived progression-free for more than 6 months.
Outcome measures
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
6 Month Progression-free Survival (PFS)
|
13 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 yearsNumber of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Partial Response
|
5 participants
|
—
|
—
|
—
|
—
|
|
Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Stable Disease
|
22 participants
|
—
|
—
|
—
|
—
|
|
Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Increase Disease
|
21 participants
|
—
|
—
|
—
|
—
|
|
Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Indeterminate
|
6 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and evaluable patients.
Outcome measures
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
Grade 2 (CTCAE v 3.0)
n=54 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=54 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=54 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
n=54 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Leukopenia
|
14 Participants
|
14 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Thrombocytopenia
|
18 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Neutropenia
|
6 Participants
|
12 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Anemia
|
20 Participants
|
19 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Other hematologic
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Allergy/Immunology
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Auditory/Ear
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Cardiac
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Coagulation
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Constitutional
|
23 Participants
|
15 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Dermatologic
|
24 Participants
|
10 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Nausea
|
19 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Vomiting
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Gastrointestinal
|
16 Participants
|
19 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Genitourinary/Renal
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Hemorrhage
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Infection
|
0 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Lymphatics
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Metabolic
|
17 Participants
|
12 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Musculoskeletal
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Neurosensory
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Other Neurological
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Ocular/Visual
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Pain
|
13 Participants
|
7 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Pulmonary
|
17 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Sexual/Reproductive
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Vascular
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months up to 5 yearsPopulation: Eligible and evaluable patients
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Duration of Progression-free Survival
|
3.19 months
Interval 1.74 to 5.82
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.Population: Eligible and evaluable patients.
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Duration of Overall Survival
|
11.60 months
Interval 6.83 to 22.83
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from study entry until end of study treatmentOutcome measures
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Reason Off Study Therapy
Disease Progression
|
37 participants
|
—
|
—
|
—
|
—
|
|
Reason Off Study Therapy
Refused Further Treatment
|
5 participants
|
—
|
—
|
—
|
—
|
|
Reason Off Study Therapy
Toxicity as permitted
|
8 participants
|
—
|
—
|
—
|
—
|
|
Reason Off Study Therapy
Other
|
3 participants
|
—
|
—
|
—
|
—
|
|
Reason Off Study Therapy
Unspecified
|
1 participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study entry up to 2 yearsPatients alive or dead after 24 months from time of study entry
Outcome measures
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Patient Vital Status
Alive with disease progression
|
19 participants
|
—
|
—
|
—
|
—
|
|
Patient Vital Status
Dead from disease
|
29 participants
|
—
|
—
|
—
|
—
|
|
Patient Vital Status
Dead from neither treatment nor disease
|
1 participants
|
—
|
—
|
—
|
—
|
|
Patient Vital Status
Alive without disease progression
|
5 participants
|
—
|
—
|
—
|
—
|
Adverse Events
Treatment (Temsirolimus)
Serious events: 5 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
|---|---|
|
General disorders
Fatigue
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Insomnia
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Ileus
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
9.3%
5/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dehydration
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Creatinine
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Memory Impairment
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain: Head/Headache
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain: Abdominal Pain Nos
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
2/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Obstruction, Gu - Bladder
|
1.9%
1/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
3.7%
2/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
Other adverse events
| Measure |
Treatment (Temsirolimus)
n=54 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.
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
9.3%
5/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Neutrophils
|
35.2%
19/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Platelets
|
44.4%
24/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Leukocytes
|
51.9%
28/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
81.5%
44/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Fibrinogen
|
5.6%
3/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Ptt
|
5.6%
3/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Fever
|
11.1%
6/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Weight Loss
|
16.7%
9/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Rigors/Chills
|
5.6%
3/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Fatigue
|
79.6%
43/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Insomnia
|
9.3%
5/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
16.7%
9/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.3%
5/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
46.3%
25/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.6%
3/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
6/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Endocrine disorders
Hot Flashes
|
13.0%
7/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Heartburn
|
9.3%
5/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
7.4%
4/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Taste Alteration
|
9.3%
5/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
37.0%
20/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
27.8%
15/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
13/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Anorexia
|
40.7%
22/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dehydration
|
7.4%
4/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.9%
14/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Nausea
|
51.9%
28/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
24/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
9.3%
5/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
16.7%
9/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
20.4%
11/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Ast
|
27.8%
15/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
55.6%
30/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Creatinine
|
24.1%
13/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.2%
12/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Alt
|
9.3%
5/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
18.5%
10/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Bilirubin
|
5.6%
3/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.6%
3/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.3%
5/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.0%
7/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
51.9%
28/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
9/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
24.1%
13/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
24.1%
13/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
9/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Mood Alteration - Depression
|
14.8%
8/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
18.5%
10/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Dizziness
|
11.1%
6/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Neuropathy-Sensory
|
40.7%
22/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Eye disorders
Blurred Vision
|
5.6%
3/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain - Other
|
5.6%
3/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain: Chest /Thorax Nos
|
7.4%
4/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain: Head/Headache
|
22.2%
12/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain: Extremity-Limb
|
13.0%
7/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain: Back
|
11.1%
6/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain: Joint
|
7.4%
4/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain: Abdominal Pain Nos
|
33.3%
18/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain: Muscle
|
7.4%
4/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
5.6%
3/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.2%
19/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
18/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Frequency
|
16.7%
9/54 • All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
Additional Information
Melissa Leventhal
Gynecologic Oncology Group Statistical and Data Center
Phone: 716-845-4030
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60