Trial Outcomes & Findings for Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC) (NCT NCT01016769)
NCT ID: NCT01016769
Last Updated: 2019-06-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
2 years
Results posted on
2019-06-26
Participant Flow
Participant milestones
| Measure |
Phase 1, Dose Level 1
Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5
|
Phase 1, Dose Level 2
Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC
|
Phase 1, Dose Level 3
Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
|
Phase 2, Dose Level 3
Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
7
|
30
|
|
Overall Study
COMPLETED
|
3
|
6
|
6
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
Baseline characteristics by cohort
| Measure |
Phase 1, Dose Level 1
n=4 Participants
Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5
|
Phase 1, Dose Level 2
n=7 Participants
Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC
|
Phase 1, Dose Level 3
n=7 Participants
Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
|
Phase 2, Dose Level 3
n=30 Participants
Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The phase II recommended dose of Temsirolimus was established at dose level three (Carboplatin AUC 1.5, Taxol 80 mg/m2, Temsirolimus 25 mg). 6 participants treated on Phase I, dose level 3 and 30 participants treated on the Phase II portion were combined for analysis.
Outcome measures
| Measure |
Temsirolimus + Weekly Paclitaxel + Carboplatin
n=36 Participants
In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed.
|
|---|---|
|
Phase II Recommended Dose for the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin.
|
25 mg
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The phase II recommended dose of Temsirolimus was established at dose level three (Carboplatin AUC 1.5, Taxol 80 mg/m2, Temsirolimus 25 mg). 6 participants treated on Phase I, dose level 3 and 30 participants treated on the Phase II portion were combined for analysis.
Evaluation of target lesions: Complete Response - disappearance of all target lesions Partial Response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Progressive Disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one of more new lesions Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started
Outcome measures
| Measure |
Temsirolimus + Weekly Paclitaxel + Carboplatin
n=36 Participants
In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed.
|
|---|---|
|
To Determine the Objective Response Rate (CR or PR) After Two Cycles of Treatment With the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin as Palliative Therapy for Recurrent or Metastatic HNSCC
Partial Response
|
15 Participants
|
|
To Determine the Objective Response Rate (CR or PR) After Two Cycles of Treatment With the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin as Palliative Therapy for Recurrent or Metastatic HNSCC
Stable Disease
|
19 Participants
|
|
To Determine the Objective Response Rate (CR or PR) After Two Cycles of Treatment With the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin as Palliative Therapy for Recurrent or Metastatic HNSCC
Not Evaluable
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsSafety will be assessed in terms of AEs according to CTCAE version 3.0
Outcome measures
| Measure |
Temsirolimus + Weekly Paclitaxel + Carboplatin
n=48 Participants
In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed.
|
|---|---|
|
Number of Participants Who Experienced Adverse Events
|
48 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The phase II recommended dose of Temsirolimus was established at dose level three (Carboplatin AUC 1.5, Taxol 80 mg/m2, Temsirolimus 25 mg). 7 participants treated on Phase I, dose level 3 and 30 participants treated on the Phase II portion were combined for analysis.
Outcome measures
| Measure |
Temsirolimus + Weekly Paclitaxel + Carboplatin
n=37 Participants
In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed.
|
|---|---|
|
Median Overall Survival
|
5.9 months
Interval 4.8 to 7.1
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Temsirolimus + Weekly Paclitaxel + Carboplatin
n=21 Participants
In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed.
|
|---|---|
|
Number of Participants With Potential Molecular Markers of Resistance to mTOR Inhibition
PTEN R130Q Mutation
|
1 Participants
|
|
Number of Participants With Potential Molecular Markers of Resistance to mTOR Inhibition
PIK3CA Mutation
|
4 Participants
|
|
Number of Participants With Potential Molecular Markers of Resistance to mTOR Inhibition
AKT3 S472F Mutation
|
1 Participants
|
|
Number of Participants With Potential Molecular Markers of Resistance to mTOR Inhibition
TSC2 Mutation
|
2 Participants
|
|
Number of Participants With Potential Molecular Markers of Resistance to mTOR Inhibition
TSC1 Mutation
|
2 Participants
|
Adverse Events
Phase 1, Dose Level 1
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1, Dose Level 2
Serious events: 4 serious events
Other events: 7 other events
Deaths: 6 deaths
Phase 1, Dose Level 3
Serious events: 5 serious events
Other events: 7 other events
Deaths: 7 deaths
Phase 2, Dose Level 3
Serious events: 21 serious events
Other events: 30 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Phase 1, Dose Level 1
n=4 participants at risk
Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5
|
Phase 1, Dose Level 2
n=7 participants at risk
Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC
|
Phase 1, Dose Level 3
n=7 participants at risk
Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
|
Phase 2, Dose Level 3
n=30 participants at risk
Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allerg rhinitis (w sneez, nas stuff, postnas drip)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Investigations
ALT, SGPT
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Investigations
AST, SGOT
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Calcium, high (hypercalcemia)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Calcium, low (hypocalcemia)
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Cardiac disorders
Conduct abnorm AV Block- 2nd deg Mobitz type II
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Investigations
Creatinine
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
General disorders
Death not assoc w CTCAE term- Sudden death
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Dysphagia (Difficulty swallowing)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
28.6%
2/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
28.6%
2/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
General disorders
Edema: head and neck
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Fistula, pulm/upp respir - Trachea
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Investigations
Hemoglobin
|
25.0%
1/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Bronchopulmonary NOS
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Nose
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Hemorrhage, Rectum
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Gastrointestinal disorders
Hemorrhage, Upper GI NOS
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Pneumonia(lung)
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Infections and infestations
Inf unknown ANC-Peripheral nerve
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Infections and infestations
Inf unknown ANC-Pneumonia(lung)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Bone (osteomyelitis)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Lung (pneumonia)
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Infections and infestations
Infection, other
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Investigations
INR
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Investigations
Lymphopenia
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Psychiatric disorders
Mental status
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Whole body/general
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
14.3%
1/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
General disorders
Pain - Face
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Investigations
Platelets
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulm/upp respiratory - Other (spec)
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Gastrointestinal disorders
Stricture/stenosis, Esophagus
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Endocrine disorders
Thyroid function, high
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
28.6%
2/7 • 2 years
|
3.3%
1/30 • 2 years
|
Other adverse events
| Measure |
Phase 1, Dose Level 1
n=4 participants at risk
Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5
|
Phase 1, Dose Level 2
n=7 participants at risk
Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC
|
Phase 1, Dose Level 3
n=7 participants at risk
Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
|
Phase 2, Dose Level 3
n=30 participants at risk
Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
75.0%
3/4 • 2 years
|
42.9%
3/7 • 2 years
|
100.0%
7/7 • 2 years
|
73.3%
22/30 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • 2 years
|
14.3%
1/7 • 2 years
|
57.1%
4/7 • 2 years
|
50.0%
15/30 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • 2 years
|
42.9%
3/7 • 2 years
|
28.6%
2/7 • 2 years
|
36.7%
11/30 • 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
50.0%
2/4 • 2 years
|
85.7%
6/7 • 2 years
|
85.7%
6/7 • 2 years
|
90.0%
27/30 • 2 years
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
100.0%
4/4 • 2 years
|
71.4%
5/7 • 2 years
|
100.0%
7/7 • 2 years
|
83.3%
25/30 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
4/4 • 2 years
|
100.0%
7/7 • 2 years
|
85.7%
6/7 • 2 years
|
100.0%
30/30 • Number of events 35 • 2 years
|
|
Investigations
Leukocytes (total WBC)
|
100.0%
4/4 • 2 years
|
71.4%
5/7 • 2 years
|
85.7%
6/7 • 2 years
|
86.7%
26/30 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 2 years
|
14.3%
1/7 • 2 years
|
42.9%
3/7 • 2 years
|
40.0%
12/30 • 2 years
|
|
General disorders
Pain - Pain NOS
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
33.3%
10/30 • 2 years
|
|
Investigations
Platelets
|
75.0%
3/4 • 2 years
|
57.1%
4/7 • 2 years
|
71.4%
5/7 • 2 years
|
76.7%
23/30 • 2 years
|
|
Investigations
Cholesterol,high(hypercholestremia)
|
50.0%
2/4 • 2 years
|
42.9%
3/7 • 2 years
|
57.1%
4/7 • 2 years
|
76.7%
23/30 • 2 years
|
|
General disorders
Edema: head and neck
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
20.0%
6/30 • 2 years
|
|
Investigations
Lymphopenia
|
75.0%
3/4 • 2 years
|
85.7%
6/7 • 2 years
|
57.1%
4/7 • 2 years
|
56.7%
17/30 • 2 years
|
|
Nervous system disorders
Neuropathy: sensory
|
75.0%
3/4 • 2 years
|
57.1%
4/7 • 2 years
|
57.1%
4/7 • 2 years
|
63.3%
19/30 • 2 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
50.0%
2/4 • 2 years
|
28.6%
2/7 • 2 years
|
42.9%
3/7 • 2 years
|
43.3%
13/30 • 2 years
|
|
General disorders
Pain - face
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
28.6%
2/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Trglycrde, high (hypertriglyceridemia)
|
50.0%
2/4 • 2 years
|
14.3%
1/7 • 2 years
|
42.9%
3/7 • 2 years
|
43.3%
13/30 • 2 years
|
|
Investigations
ALT, SGPT
|
25.0%
1/4 • 2 years
|
28.6%
2/7 • 2 years
|
28.6%
2/7 • 2 years
|
53.3%
16/30 • 2 years
|
|
Investigations
Alkaline phosphatase
|
25.0%
1/4 • 2 years
|
42.9%
3/7 • 2 years
|
42.9%
3/7 • 2 years
|
33.3%
10/30 • 2 years
|
|
Gastrointestinal disorders
Dysphagia (Difficulty swallowing)
|
50.0%
2/4 • 2 years
|
71.4%
5/7 • 2 years
|
71.4%
5/7 • 2 years
|
60.0%
18/30 • 2 years
|
|
Investigations
AST, SGOT
|
25.0%
1/4 • 2 years
|
71.4%
5/7 • 2 years
|
42.9%
3/7 • 2 years
|
30.0%
9/30 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
28.6%
2/7 • 2 years
|
16.7%
5/30 • 2 years
|
|
Metabolism and nutrition disorders
Calcium, low (hypocalcemia)
|
25.0%
1/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • 2 years
|
14.3%
1/7 • 2 years
|
28.6%
2/7 • 2 years
|
23.3%
7/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
25.0%
1/4 • 2 years
|
14.3%
1/7 • 2 years
|
28.6%
2/7 • 2 years
|
33.3%
10/30 • 2 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
28.6%
2/7 • 2 years
|
16.7%
5/30 • 2 years
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • 2 years
|
14.3%
1/7 • 2 years
|
28.6%
2/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Investigations
INR
|
25.0%
1/4 • 2 years
|
14.3%
1/7 • 2 years
|
42.9%
3/7 • 2 years
|
23.3%
7/30 • 2 years
|
|
Infections and infestations
Pneumonia/Lung Infection
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
25.0%
1/4 • 2 years
|
28.6%
2/7 • 2 years
|
28.6%
2/7 • 2 years
|
33.3%
10/30 • 2 years
|
|
Gastrointestinal disorders
Mucositis - oral cavity
|
25.0%
1/4 • 2 years
|
100.0%
7/7 • 2 years
|
57.1%
4/7 • 2 years
|
56.7%
17/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Nervous system disorders
Pain - Head/headache
|
25.0%
1/4 • 2 years
|
14.3%
1/7 • 2 years
|
57.1%
4/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
25.0%
1/4 • 2 years
|
28.6%
2/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
25.0%
1/4 • 2 years
|
42.9%
3/7 • 2 years
|
85.7%
6/7 • 2 years
|
36.7%
11/30 • 2 years
|
|
Eye disorders
Vision-blurred vision
|
25.0%
1/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
0.00%
0/4 • 2 years
|
42.9%
3/7 • 2 years
|
28.6%
2/7 • 2 years
|
20.0%
6/30 • 2 years
|
|
Investigations
Weight Loss
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
36.7%
11/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 2 years
|
71.4%
5/7 • 2 years
|
57.1%
4/7 • 2 years
|
56.7%
17/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
14.3%
1/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/4 • 2 years
|
28.6%
2/7 • 2 years
|
28.6%
2/7 • 2 years
|
30.0%
9/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Bronchopulmonary NOS
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
14.3%
1/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/4 • 2 years
|
42.9%
3/7 • 2 years
|
0.00%
0/7 • 2 years
|
20.0%
6/30 • 2 years
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
0.00%
0/4 • 2 years
|
28.6%
2/7 • 2 years
|
28.6%
2/7 • 2 years
|
20.0%
6/30 • 2 years
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
0.00%
0/4 • 2 years
|
28.6%
2/7 • 2 years
|
42.9%
3/7 • 2 years
|
40.0%
12/30 • 2 years
|
|
Gastrointestinal disorders
Pain - Dental/Teeth/Peridontal
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/4 • 2 years
|
28.6%
2/7 • 2 years
|
14.3%
1/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Gastrointestinal disorders
Pain - oral cavity
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
28.6%
2/7 • 2 years
|
23.3%
7/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Trismus (dffclty,pain whn opn mouth)
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
57.1%
4/7 • 2 years
|
26.7%
8/30 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 2 years
|
28.6%
2/7 • 2 years
|
42.9%
3/7 • 2 years
|
20.0%
6/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
14.3%
1/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Investigations
Creatinine
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
14.3%
1/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
14.3%
1/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
0.00%
0/4 • 2 years
|
14.3%
1/7 • 2 years
|
28.6%
2/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
General disorders
Edema: limb
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
28.6%
2/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Infections and infestations
Infection, other
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
42.9%
3/7 • 2 years
|
33.3%
10/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
28.6%
2/7 • 2 years
|
30.0%
9/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Nervous system disorders
Voice changes/dysarthria
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
28.6%
2/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Ear and labyrinth disorders
Pain - External ear
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
57.1%
4/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Cardiac disorders
Vent arrhythmia- Ventricular tachycardia
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
3.3%
1/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
16.7%
5/30 • 2 years
|
|
Eye disorders
Ocular/Visual - Other (specify)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Gastrointestinal disorders
Fistula, GI- Oral cavity
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allerg rhinitis (w sneez, nas stuff, postnas drip)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Nose
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
20.0%
6/30 • 2 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
14.3%
1/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
5/30 • 2 years
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
23.3%
7/30 • 2 years
|
|
General disorders
Hemorrhage/Bleeding, other
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
General disorders
Flu-like syndrome
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Extremity-lower
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Gastrointestinal disorders
Gastritis (incl bile reflux gastritis)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
3/30 • 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Ear and labyrinth disorders
Auditory/Ear, other
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Endocrine disorders
Thyroid function, low
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Investigations
PTT
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Psychiatric disorders
Mood alteration - Depression
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
13.3%
4/30 • 2 years
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/7 • 2 years
|
6.7%
2/30 • 2 years
|
Additional Information
Dr. David Pfister, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4237
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place