Trial Outcomes & Findings for Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed By Surgery (NCT NCT01026792)
NCT ID: NCT01026792
Last Updated: 2015-09-10
Results Overview
Response is defined as a 30% decrease in the sum of the longest diameters of the target lesions (PR) or complete disappearance of disease and symptoms (CR) for at least 4 weeks as assessed by Response Evaluation Criteria in Solid Tumors 1.1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2015-09-10
Participant Flow
Participant milestones
| Measure |
Treatment (Temsirolimus)
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Temsirolimus)
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Temsirolimus)
n=37 Participants
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Patients evaluable for response
Response is defined as a 30% decrease in the sum of the longest diameters of the target lesions (PR) or complete disappearance of disease and symptoms (CR) for at least 4 weeks as assessed by Response Evaluation Criteria in Solid Tumors 1.1
Outcome measures
| Measure |
Treatment (Temsirolimus)
n=33 Participants
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response Rate
|
3 percentage of patients with response
Interval 0.1 to 15.8
|
Adverse Events
Treatment (Temsirolimus)
Serious events: 15 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Temsirolimus)
n=37 participants at risk
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Edema: limb
|
5.4%
2/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
1/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.7%
1/37 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
5.4%
2/37 • 3 years
|
|
General disorders
Death NOS
|
16.2%
6/37 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
5.4%
2/37 • 3 years
|
|
Nervous system disorders
Paresthesia
|
2.7%
1/37 • 3 years
|
|
Renal and urinary disorders
Other renal and urinary disorders
|
5.4%
2/37 • 3 years
|
|
Renal and urinary disorders
Urinary tract infection
|
5.4%
2/37 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.7%
1/37 • 3 years
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
2.7%
1/37 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
2/37 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
1/37 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • 3 years
|
|
General disorders
Fatigue
|
2.7%
1/37 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.7%
1/37 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
2.7%
1/37 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
1/37 • 3 years
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.7%
1/37 • 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.7%
1/37 • 3 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.7%
1/37 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
2.7%
1/37 • 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.4%
2/37 • 3 years
|
|
Investigations
Creatinine increased
|
2.7%
1/37 • 3 years
|
Other adverse events
| Measure |
Treatment (Temsirolimus)
n=37 participants at risk
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.5%
5/37 • 3 years
|
|
Cardiac disorders
Palpitations
|
5.4%
2/37 • 3 years
|
|
Ear and labyrinth disorders
Other ear and labyrinth disorders
|
5.4%
2/37 • 3 years
|
|
Endocrine disorders
Hypothyroidism
|
8.1%
3/37 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
27.0%
10/37 • 3 years
|
|
Gastrointestinal disorders
Bloating
|
8.1%
3/37 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
54.1%
20/37 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
40.5%
15/37 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
10.8%
4/37 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
16.2%
6/37 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
8.1%
3/37 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
10.8%
4/37 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.1%
3/37 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.4%
2/37 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
35.1%
13/37 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
54.1%
20/37 • 3 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
8.1%
3/37 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
32.4%
12/37 • 3 years
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
35.1%
13/37 • 3 years
|
|
General disorders
Chills
|
10.8%
4/37 • 3 years
|
|
General disorders
Edema face
|
8.1%
3/37 • 3 years
|
|
General disorders
Edema limbs
|
40.5%
15/37 • 3 years
|
|
General disorders
Fatigue
|
81.1%
30/37 • 3 years
|
|
General disorders
Fever
|
10.8%
4/37 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
5.4%
2/37 • 3 years
|
|
General disorders
Pain
|
24.3%
9/37 • 3 years
|
|
General disorders
Other general disorders, administration site conditions
|
5.4%
2/37 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
18.9%
7/37 • 3 years
|
|
Infections and infestations
Other infections and infestations
|
8.1%
3/37 • 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
10.8%
4/37 • 3 years
|
|
Investigations
Weight gain
|
8.1%
3/37 • 3 years
|
|
Investigations
Weight loss
|
8.1%
3/37 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
45.9%
17/37 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
8.1%
3/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
2/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.4%
2/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
48.6%
18/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
8.1%
3/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.8%
4/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.4%
2/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.8%
4/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.1%
3/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.5%
15/37 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal and connective tissue disorder
|
13.5%
5/37 • 3 years
|
|
Nervous system disorders
Dizziness
|
8.1%
3/37 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
13.5%
5/37 • 3 years
|
|
Nervous system disorders
Headache
|
35.1%
13/37 • 3 years
|
|
Nervous system disorders
Paresthesia
|
5.4%
2/37 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
21.6%
8/37 • 3 years
|
|
Nervous system disorders
Somnolence
|
5.4%
2/37 • 3 years
|
|
Psychiatric disorders
Anxiety
|
10.8%
4/37 • 3 years
|
|
Psychiatric disorders
Depression
|
10.8%
4/37 • 3 years
|
|
Psychiatric disorders
Insomnia
|
48.6%
18/37 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
13.5%
5/37 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
18.9%
7/37 • 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
5.4%
2/37 • 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
10.8%
4/37 • 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
5.4%
2/37 • 3 years
|
|
Renal and urinary disorders
Other renal and urinary disorders
|
13.5%
5/37 • 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
13.5%
5/37 • 3 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
13.5%
5/37 • 3 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
10.8%
4/37 • 3 years
|
|
Reproductive system and breast disorders
Other reproductive system and breast disorders
|
5.4%
2/37 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.3%
9/37 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.3%
9/37 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.1%
3/37 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.4%
2/37 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.4%
2/37 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.1%
3/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.1%
3/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.4%
2/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
8.1%
3/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.4%
2/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.5%
5/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
18.9%
7/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.8%
14/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.4%
2/37 • 3 years
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
18.9%
7/37 • 3 years
|
|
Vascular disorders
Hot flashes
|
5.4%
2/37 • 3 years
|
|
Vascular disorders
Hypertension
|
13.5%
5/37 • 3 years
|
|
Vascular disorders
Lymphedema
|
10.8%
4/37 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
13.5%
5/37 • 3 years
|
Additional Information
Dr. Anna Tinker
BC Cancer Agency, Vancouver Clinic, Vancouver, BC, Canada
Phone: 604 877 6217
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60