Trial Outcomes & Findings for Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer (NCT NCT00072176)
NCT ID: NCT00072176
Last Updated: 2015-02-23
Results Overview
Defined as proportion of patients with 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response) and confirmed on independent radiology review.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2015-02-23
Participant Flow
Patients were recruited from 10 participating centers across Canada between May 2004 and June 2007.
Participant milestones
| Measure |
Group A
Chemotherapy naive 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
laboratory biomarker analysis: Correlative studies
|
Group B
Chemotherapy treated 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
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
28
|
|
Overall Study
COMPLETED
|
33
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group A
Chemotherapy naive 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
laboratory biomarker analysis: Correlative studies
|
Group B
Chemotherapy treated 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
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Group A
n=33 Participants
Chemotherapy naive 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
laboratory biomarker analysis: Correlative studies
|
Group B
n=27 Participants
Chemotherapy treated 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
laboratory biomarker analysis: Correlative studies
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
60 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
33 participants
n=5 Participants
|
27 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Patients who were evaluable for response.
Defined as proportion of patients with 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response) and confirmed on independent radiology review.
Outcome measures
| Measure |
Group A
n=29 Participants
Chemotherapy naive 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
laboratory biomarker analysis: Correlative studies
|
Group B
n=25 Participants
Chemotherapy treated 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
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Objective Clinical Response Rate
|
13.8 percentage of patients with response
Interval 3.9 to 31.7
|
4.0 percentage of patients with response
Interval 0.1 to 10.4
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: All patients who were evaluable for response
Time to tumor progression or death
Outcome measures
| Measure |
Group A
n=29 Participants
Chemotherapy naive 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
laboratory biomarker analysis: Correlative studies
|
Group B
n=25 Participants
Chemotherapy treated 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
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Progression-free Survival (Tumor Progression)
|
7.33 months
Interval 3.61 to 9.86
|
3.25 months
Interval 1.97 to 3.84
|
Adverse Events
Group A
Serious events: 11 serious events
Other events: 33 other events
Deaths: 0 deaths
Group B
Serious events: 9 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=33 participants at risk
Chemotherapy naive 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
laboratory biomarker analysis: Correlative studies
|
Group B
n=27 participants at risk
Chemotherapy treated 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
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Limb Edema
|
3.0%
1/33
|
0.00%
0/27
|
|
Gastrointestinal disorders
Hospitalization for dehydration
|
3.0%
1/33
|
7.4%
2/27
|
|
Renal and urinary disorders
Renal failure
|
3.0%
1/33
|
0.00%
0/27
|
|
Nervous system disorders
Hospitalization for spinal cord compression
|
3.0%
1/33
|
3.7%
1/27
|
|
Investigations
Hospitalization for hyperglycemia
|
3.0%
1/33
|
0.00%
0/27
|
|
Gastrointestinal disorders
Hospitalization for bowel obstruction and enteritis
|
3.0%
1/33
|
0.00%
0/27
|
|
General disorders
Hospitalization for chest pain
|
3.0%
1/33
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for pulmonary embolism
|
3.0%
1/33
|
0.00%
0/27
|
|
General disorders
hospitalization for abdominal pain
|
3.0%
1/33
|
0.00%
0/27
|
|
Investigations
Hospitalization for hypokalemia
|
3.0%
1/33
|
7.4%
2/27
|
|
Gastrointestinal disorders
Hospitalization for anorexia
|
3.0%
1/33
|
0.00%
0/27
|
|
General disorders
Hospitalization for gastrointestinal pain
|
3.0%
1/33
|
0.00%
0/27
|
|
Renal and urinary disorders
Hospitalization for renal obstruction
|
3.0%
1/33
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for pneumonitis
|
3.0%
1/33
|
3.7%
1/27
|
|
General disorders
Hospitalization for leg pain
|
3.0%
1/33
|
0.00%
0/27
|
|
Gastrointestinal disorders
Hospitalization for bowel obstruction
|
3.0%
1/33
|
0.00%
0/27
|
|
Investigations
Hospitalization for Hyponatremia
|
0.00%
0/33
|
3.7%
1/27
|
|
Gastrointestinal disorders
Hospitalization for Nausea
|
0.00%
0/33
|
3.7%
1/27
|
|
General disorders
Hospitalization for Fatigue
|
0.00%
0/33
|
3.7%
1/27
|
|
Gastrointestinal disorders
Hospitalization for Vomiting
|
0.00%
0/33
|
7.4%
2/27
|
|
Gastrointestinal disorders
Hospitalization for diarrhea
|
0.00%
0/33
|
7.4%
2/27
|
|
Infections and infestations
Hospitalization for Urosepsis
|
0.00%
0/33
|
3.7%
1/27
|
|
Blood and lymphatic system disorders
Hospitalization for Anemia
|
0.00%
0/33
|
3.7%
1/27
|
|
Gastrointestinal disorders
Hospitalization for Fistula
|
0.00%
0/33
|
3.7%
1/27
|
|
Blood and lymphatic system disorders
Thrombosis
|
0.00%
0/33
|
3.7%
1/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization for Impending Fracture of Lytic Lesion
|
0.00%
0/33
|
3.7%
1/27
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Dyspnea
|
0.00%
0/33
|
3.7%
1/27
|
|
Ear and labyrinth disorders
Hospitalization for Ear Pain
|
0.00%
0/33
|
3.7%
1/27
|
|
Nervous system disorders
Hospitalization for Facial Nerve & Vocal Cord Paralysis
|
0.00%
0/33
|
3.7%
1/27
|
Other adverse events
| Measure |
Group A
n=33 participants at risk
Chemotherapy naive 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
laboratory biomarker analysis: Correlative studies
|
Group B
n=27 participants at risk
Chemotherapy treated 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
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
6.1%
2/33
|
3.7%
1/27
|
|
Immune system disorders
Rhinitis
|
21.2%
7/33
|
7.4%
2/27
|
|
Cardiac disorders
Supraventricular arrhythmia Atrial tachycardia
|
6.1%
2/33
|
0.00%
0/27
|
|
Cardiac disorders
Supraventricular arrhythmia Sinus tachycardia
|
3.0%
1/33
|
11.1%
3/27
|
|
Cardiac disorders
Supraventricular arrhythmia Tachycardia
|
3.0%
1/33
|
11.1%
3/27
|
|
Cardiac disorders
Hypertension
|
12.1%
4/33
|
3.7%
1/27
|
|
Cardiac disorders
Hypotension
|
6.1%
2/33
|
0.00%
0/27
|
|
Cardiac disorders
Cardiac General - Other
|
6.1%
2/33
|
3.7%
1/27
|
|
General disorders
Fatigue
|
84.8%
28/33
|
77.8%
21/27
|
|
General disorders
Fever
|
18.2%
6/33
|
11.1%
3/27
|
|
General disorders
Insomnia
|
27.3%
9/33
|
25.9%
7/27
|
|
General disorders
Rigors/chills
|
15.2%
5/33
|
14.8%
4/27
|
|
Skin and subcutaneous tissue disorders
Acne
|
15.2%
5/33
|
11.1%
3/27
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
3/33
|
14.8%
4/27
|
|
Skin and subcutaneous tissue disorders
Bruising
|
21.2%
7/33
|
7.4%
2/27
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.2%
7/33
|
14.8%
4/27
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
9.1%
3/33
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
18.2%
6/33
|
7.4%
2/27
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
42.4%
14/33
|
14.8%
4/27
|
|
Skin and subcutaneous tissue disorders
Rash
|
48.5%
16/33
|
48.1%
13/27
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
6.1%
2/33
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
12.1%
4/33
|
11.1%
3/27
|
|
Endocrine disorders
Hot flashes
|
3.0%
1/33
|
7.4%
2/27
|
|
Gastrointestinal disorders
Anorexia
|
39.4%
13/33
|
59.3%
16/27
|
|
Gastrointestinal disorders
Constipation
|
42.4%
14/33
|
40.7%
11/27
|
|
Gastrointestinal disorders
Dehydration
|
12.1%
4/33
|
7.4%
2/27
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
9/33
|
51.9%
14/27
|
|
Gastrointestinal disorders
Distension
|
18.2%
6/33
|
3.7%
1/27
|
|
Gastrointestinal disorders
Dry mouth
|
21.2%
7/33
|
11.1%
3/27
|
|
Gastrointestinal disorders
Flatulence
|
12.1%
4/33
|
3.7%
1/27
|
|
Gastrointestinal disorders
Heartburn
|
12.1%
4/33
|
25.9%
7/27
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.1%
2/33
|
0.00%
0/27
|
|
Gastrointestinal disorders
Mucositis (clinical exam) Oral cavity
|
6.1%
2/33
|
0.00%
0/27
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) Oral cavity
|
63.6%
21/33
|
66.7%
18/27
|
|
Gastrointestinal disorders
Nausea
|
48.5%
16/33
|
55.6%
15/27
|
|
Gastrointestinal disorders
Taste alteration
|
42.4%
14/33
|
29.6%
8/27
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
12/33
|
37.0%
10/27
|
|
Gastrointestinal disorders
GI - Other
|
9.1%
3/33
|
7.4%
2/27
|
|
Blood and lymphatic system disorders
Hemorrhage pulmonary Nose
|
24.2%
8/33
|
14.8%
4/27
|
|
Blood and lymphatic system disorders
Hemorrhage, GU Urinary NOS
|
6.1%
2/33
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Hemorrhage, GU Vagina
|
9.1%
3/33
|
3.7%
1/27
|
|
Infections and infestations
Infection with normal ANC Lip/perioral
|
12.1%
4/33
|
3.7%
1/27
|
|
Infections and infestations
Infection with normal ANC Lung
|
6.1%
2/33
|
0.00%
0/27
|
|
Infections and infestations
Infection with normal ANC Skin
|
12.1%
4/33
|
0.00%
0/27
|
|
Infections and infestations
Infection with normal ANC Ungual
|
9.1%
3/33
|
0.00%
0/27
|
|
Infections and infestations
IInfection with normal ANC Upper airway NOS
|
6.1%
2/33
|
3.7%
1/27
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
6.1%
2/33
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Edema: limb
|
57.6%
19/33
|
18.5%
5/27
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.1%
2/33
|
3.7%
1/27
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Extremity-lower
|
6.1%
2/33
|
11.1%
3/27
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33
|
14.8%
4/27
|
|
Nervous system disorders
Mood alteration Anxiety
|
18.2%
6/33
|
18.5%
5/27
|
|
Nervous system disorders
Mood alteration Depression
|
12.1%
4/33
|
7.4%
2/27
|
|
Nervous system disorders
Neuropathy-sensory
|
21.2%
7/33
|
37.0%
10/27
|
|
Nervous system disorders
Somnolence
|
6.1%
2/33
|
3.7%
1/27
|
|
Nervous system disorders
Neurology - Other
|
3.0%
1/33
|
11.1%
3/27
|
|
Eye disorders
Dry eye
|
6.1%
2/33
|
3.7%
1/27
|
|
Eye disorders
Watery eye
|
6.1%
2/33
|
0.00%
0/27
|
|
Eye disorders
Ocular - Other
|
6.1%
2/33
|
3.7%
1/27
|
|
General disorders
Pain Abdomen NOS
|
60.6%
20/33
|
51.9%
14/27
|
|
General disorders
Pain Back
|
27.3%
9/33
|
37.0%
10/27
|
|
General disorders
Pain Bladder
|
15.2%
5/33
|
14.8%
4/27
|
|
General disorders
Pain Bone
|
6.1%
2/33
|
11.1%
3/27
|
|
General disorders
Pain Chest wall
|
6.1%
2/33
|
7.4%
2/27
|
|
General disorders
Pain Chest/thorax NOS
|
9.1%
3/33
|
3.7%
1/27
|
|
General disorders
Pain Esophagus
|
6.1%
2/33
|
3.7%
1/27
|
|
General disorders
Pain Extremity-limb
|
15.2%
5/33
|
11.1%
3/27
|
|
General disorders
Pain Head/headache
|
30.3%
10/33
|
18.5%
5/27
|
|
General disorders
Pain Joint
|
18.2%
6/33
|
14.8%
4/27
|
|
General disorders
Pain Muscle
|
21.2%
7/33
|
7.4%
2/27
|
|
General disorders
Pain Neuralgia/peripheral nerve
|
6.1%
2/33
|
0.00%
0/27
|
|
General disorders
Pain - Other
|
9.1%
3/33
|
3.7%
1/27
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.1%
2/33
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
39.4%
13/33
|
40.7%
11/27
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
39.4%
13/33
|
37.0%
10/27
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
45.5%
15/33
|
37.0%
10/27
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
6.1%
2/33
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
6.1%
2/33
|
0.00%
0/27
|
|
Renal and urinary disorders
Incontinence, urinary
|
6.1%
2/33
|
3.7%
1/27
|
|
Renal and urinary disorders
Renal failure
|
6.1%
2/33
|
0.00%
0/27
|
|
Renal and urinary disorders
Urinary frequency
|
18.2%
6/33
|
3.7%
1/27
|
|
Renal and urinary disorders
Urinary retention
|
6.1%
2/33
|
3.7%
1/27
|
|
Reproductive system and breast disorders
Vaginal discharge
|
9.1%
3/33
|
18.5%
5/27
|
|
General disorders
Flu-like syndrome
|
3.0%
1/33
|
14.8%
4/27
|
|
Vascular disorders
Phlebitis
|
9.1%
3/33
|
0.00%
0/27
|
|
Vascular disorders
hrombosis/thrombus/embolism
|
6.1%
2/33
|
3.7%
1/27
|
Additional Information
Dr. Amit M. Oza
Princess Margaret Hospital, Toronto, Canada
Phone: 416 946 4501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60