Trial Outcomes & Findings for Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma (NCT NCT01009203)
NCT ID: NCT01009203
Last Updated: 2015-08-10
Results Overview
The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.
TERMINATED
PHASE2
13 participants
3 years
2015-08-10
Participant Flow
Dates of recruitment period: December, 2009 - March, 2011
Participant milestones
| Measure |
Erlotinib and Temsirolimus
Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
Received Treatment
|
12
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Erlotinib and Temsirolimus
Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Treatment-unrelated death
|
1
|
Baseline Characteristics
Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Erlotinib and Temsirolimus
n=13 Participants
Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
|
|---|---|
|
Age, Continuous
|
61.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 yearsThe time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.
Outcome measures
| Measure |
Erlotinib and Temsirolimus
n=12 Participants
Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
|
|---|---|
|
Progression Free Survival (PFS)
|
1.9 Months
Interval 0.6 to 7.4
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants who received t least one dose of on-study treatment
Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The number of patients affected by adverse events of grade 3 or higher will be reported.
Outcome measures
| Measure |
Erlotinib and Temsirolimus
n=12 Participants
Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
|
|---|---|
|
Toxicity Profile
Diarrhea
|
2 participants
|
|
Toxicity Profile
Facial/neck edema
|
1 participants
|
|
Toxicity Profile
Laryngeal edema
|
1 participants
|
|
Toxicity Profile
Asthenia
|
5 participants
|
|
Toxicity Profile
Peritonitis / infection
|
2 participants
|
|
Toxicity Profile
Anorexia
|
1 participants
|
|
Toxicity Profile
Elevated triglycerides
|
1 participants
|
|
Toxicity Profile
Aspiration pneumonia
|
1 participants
|
|
Toxicity Profile
Dyspnea
|
3 participants
|
|
Toxicity Profile
Hypoxia
|
1 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants evaluable for response
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum of the percentages of patients achieving complete and partial responses
Outcome measures
| Measure |
Erlotinib and Temsirolimus
n=9 Participants
Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
|
|---|---|
|
Overall Response Rate (ORR)
Complete response (CR)
|
0 percentage of evaluable participants
|
|
Overall Response Rate (ORR)
Partial response (PR)
|
11.1 percentage of evaluable participants
|
|
Overall Response Rate (ORR)
Overall response rate (CR + PR)
|
11.1 percentage of evaluable participants
|
SECONDARY outcome
Timeframe: 3 yearsThe time from treatment initiation to death by any cause
Outcome measures
| Measure |
Erlotinib and Temsirolimus
n=12 Participants
Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
|
|---|---|
|
Overall Survival (OS)
|
4 months
Interval 0.6 to 20.2
|
Adverse Events
Erlotinib and Temsirolimus
Serious adverse events
| Measure |
Erlotinib and Temsirolimus
n=12 participants at risk
Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
|
|---|---|
|
Infections and infestations
Device related infection
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Nervous system disorders
Cerebrovascular Ischemia
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness of breath)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
General disorders
Death
|
8.3%
1/12 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Erlotinib and Temsirolimus
n=12 participants at risk
Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
|
|---|---|
|
General disorders
Rhinitis (Runny nose)
|
8.3%
1/12 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytes decreased
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Lymphopenia (Decreased lymphocytes)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Neutrophils decreased
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Platelets decreased
|
25.0%
3/12 • Number of events 4 • 3 years
|
|
Cardiac disorders
Hypotension (Low blood pressure)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
83.3%
10/12 • Number of events 20 • 3 years
|
|
General disorders
Fever
|
16.7%
2/12 • Number of events 3 • 3 years
|
|
General disorders
Weight loss
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Fibrosis
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Induration (Hardening of the skin)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus (Itching)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
58.3%
7/12 • Number of events 16 • 3 years
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
8.3%
1/12 • Number of events 2 • 3 years
|
|
Endocrine disorders
Hypothyroidism (Low thyroid function)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Anorexia (Loss of appetite)
|
16.7%
2/12 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
6/12 • Number of events 10 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia (Heartburn)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dysphagia (Difficulty swallowing)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral (Inflammation of the mouth)
|
16.7%
2/12 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • Number of events 8 • 3 years
|
|
Gastrointestinal disorders
Taste alteration
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Infections and infestations
Gingival infection (Gum infection)
|
25.0%
3/12 • Number of events 3 • 3 years
|
|
General disorders
Edema limbs
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
General disorders
Edema: head and neck
|
33.3%
4/12 • Number of events 10 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Investigations
Hemoglobin decreased
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Investigations
Hypercholesterolemia (High cholesterol levels)
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Investigations
Hyperglycemia (High blood sugar levels)
|
25.0%
3/12 • Number of events 3 • 3 years
|
|
Investigations
Hypertriglyceridemia (High triglyceride levels)
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Investigations
Hypoalbuminemia (Low albumin levels)
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Investigations
Hypocalcemia (Low calcium levels)
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Investigations
Hypokalemia (Low potassium levels)
|
33.3%
4/12 • Number of events 6 • 3 years
|
|
Investigations
Hypomagnesemia (Low magnesium levels)
|
25.0%
3/12 • Number of events 3 • 3 years
|
|
Investigations
Hyponatremia (Low sodium levels)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Investigations
Hypophosphatemia (Low phosphate levels)
|
16.7%
2/12 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Muscle pain)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pelvic soft tissue necrosis
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Nervous system disorders
Syncope (Sudden loss of consciousness)
|
8.3%
1/12 • Number of events 2 • 3 years
|
|
General disorders
Ear, nose and throat examination abnormal
|
50.0%
6/12 • Number of events 11 • 3 years
|
|
General disorders
Patient odor
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
General disorders
Joint pain
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
General disorders
Neck pain
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
General disorders
Oral pain
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
General disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness of breath)
|
16.7%
2/12 • Number of events 5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (Fluid collection in lung lining)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax (Lung collapse)
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Vascular disorders
Vascular access complication (Clotting)
|
8.3%
1/12 • Number of events 1 • 3 years
|
Additional Information
Julie E. Bauman, MD
University of Pittsburgh Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place