Trial Outcomes & Findings for Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer (NCT NCT00645593)
NCT ID: NCT00645593
Last Updated: 2016-05-23
Results Overview
The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab. Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (\>=30% decrease in the sum of the longest diameter of target lesions).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
3 years
Results posted on
2016-05-23
Participant Flow
Participant milestones
| Measure |
Arm 1, Gemcitabine and Cisplatin
Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
|
Arm 2, Cetuximab, Gemcitabine and Cisplatin
Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
60
|
|
Overall Study
COMPLETED
|
28
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1, Gemcitabine and Cisplatin
Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
|
Arm 2, Cetuximab, Gemcitabine and Cisplatin
Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
|
|---|---|---|
|
Overall Study
Later found to be ineligible
|
1
|
0
|
Baseline Characteristics
Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Arm 1, Gemcitabine and Cisplatin
n=28 Participants
Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
|
Arm 2, Cetuximab, Gemcitabine and Cisplatin
n=60 Participants
Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
n=99 Participants
|
60.9 years
n=107 Participants
|
61 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
ECOG performance status
0
|
18 participants
n=99 Participants
|
33 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
ECOG performance status
1
|
8 participants
n=99 Participants
|
26 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
ECOG performance status
2
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Bladder primary
|
20 participants
n=99 Participants
|
45 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Distant metastasis
|
26 participants
n=99 Participants
|
54 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Local recurrence
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Unresectable disease
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Prior cystectomy or nephroureterectomy
|
10 participants
n=99 Participants
|
13 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Primary in place
|
18 participants
n=99 Participants
|
47 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Prior neoadjuvant or or adjuvant chemotherapy
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: 29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.
The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab. Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (\>=30% decrease in the sum of the longest diameter of target lesions).
Outcome measures
| Measure |
Arm 1, Gemcitabine and Cisplatin
n=28 Participants
Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
|
Arm 2, Cetuximab, Gemcitabine and Cisplatin
n=57 Participants
Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
|
|---|---|---|
|
Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2
|
57.1 percentage of participants
Interval 37.0 to 76.0
|
61.4 percentage of participants
Interval 48.0 to 74.0
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Although 60 participants were enrolled and randomized to arm 2, 1 participant withdrew consent prior to treatment and was therefore excluded from toxicity analysis.
One of the secondary outcomes was to assess the safety and tolerability of treatment for both arms. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for adverse event reporting.
Outcome measures
| Measure |
Arm 1, Gemcitabine and Cisplatin
n=28 Participants
Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
|
Arm 2, Cetuximab, Gemcitabine and Cisplatin
n=59 Participants
Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
|
|---|---|---|
|
The Number of Grade 3 to 5 Adverse Events Experienced by Arm 1 and Arm 2
|
75 adverse events
|
83 adverse events
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.
Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Arm 1, Gemcitabine and Cisplatin
n=28 Participants
Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
|
Arm 2, Cetuximab, Gemcitabine and Cisplatin
n=57 Participants
Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
|
|---|---|---|
|
Median Progression-free Survival Time in Months
|
8.5 months
Interval 5.7 to 10.4
|
7.6 months
Interval 6.1 to 8.7
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.
Median overall survival in months is provided. One participant who progressed from chemotherapy in arm 1 received cyclophosphamide and achieved long-term disease control therefore there is no upper limit for the 95% confidence interval.
Outcome measures
| Measure |
Arm 1, Gemcitabine and Cisplatin
n=28 Participants
Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
|
Arm 2, Cetuximab, Gemcitabine and Cisplatin
n=57 Participants
Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
|
|---|---|---|
|
Median Overall Survival in Months
|
17.4 Months
Interval 12.8 to
One participant who progressed from chemotherapy in arm 1 received cyclophosphamide and achieved long-term disease control therefore there is no upper limit for the 95% confidence interval.
|
14.3 Months
Interval 11.6 to 22.2
|
Adverse Events
Arm 1, Gemcitabine and Cisplatin
Serious events: 16 serious events
Other events: 29 other events
Deaths: 0 deaths
Arm 2, Cetuximab, Gemcitabine and Cisplatin
Serious events: 36 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1, Gemcitabine and Cisplatin
n=29 participants at risk
Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
|
Arm 2, Cetuximab, Gemcitabine and Cisplatin
n=60 participants at risk
Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
|
|---|---|---|
|
Vascular disorders
CNS cerebrovascular ischemia
|
3.4%
1/29 • Number of events 1
|
3.3%
2/60 • Number of events 2
|
|
Nervous system disorders
Confusion
|
0.00%
0/29
|
1.7%
1/60 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • Number of events 1
|
0.00%
0/60
|
|
General disorders
Febrile neutropenia (fever of unknown origin without documented infection)
|
6.9%
2/29 • Number of events 2
|
3.3%
2/60 • Number of events 2
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
3.4%
1/29 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
3.4%
1/29 • Number of events 1
|
0.00%
0/60
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
6.9%
2/29 • Number of events 2
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Infection - Other
|
3.4%
1/29 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
10.3%
3/29 • Number of events 3
|
11.7%
7/60 • Number of events 7
|
|
Investigations
Leukocytes (total WBC)
|
3.4%
1/29 • Number of events 1
|
5.0%
3/60 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Number of events 1
|
8.3%
5/60 • Number of events 7
|
|
Nervous system disorders
Neurology - Other
|
3.4%
1/29 • Number of events 1
|
0.00%
0/60
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
17.2%
5/29 • Number of events 5
|
13.3%
8/60 • Number of events 10
|
|
General disorders
Pain
|
6.9%
2/29 • Number of events 2
|
8.3%
5/60 • Number of events 5
|
|
Investigations
Platelets
|
3.4%
1/29 • Number of events 3
|
11.7%
7/60 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
3.4%
1/29 • Number of events 1
|
0.00%
0/60
|
|
Renal and urinary disorders
Renal failure
|
3.4%
1/29 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/60
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
10.3%
3/29 • Number of events 3
|
11.7%
7/60 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1
|
3.3%
2/60 • Number of events 2
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/29
|
3.3%
2/60 • Number of events 2
|
|
Cardiac disorders
Cardiac General - Other
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term
|
0.00%
0/29
|
3.3%
2/60 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Edema: limb
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/29
|
5.0%
3/60 • Number of events 4
|
|
General disorders
Fever (in the absence of neutropenia)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/29
|
3.3%
2/60 • Number of events 2
|
|
Renal and urinary disorders
Hemorrhage, GU
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/29
|
5.0%
3/60 • Number of events 3
|
|
Nervous system disorders
Insomnia
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/29
|
5.0%
3/60 • Number of events 5
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/29
|
3.3%
2/60 • Number of events 2
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction, GI
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Renal and urinary disorders
Obstruction, GU
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Vascular disorders
Peripheral arterial ischemia
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/29
|
3.3%
2/60 • Number of events 2
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/29
|
10.0%
6/60 • Number of events 7
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Ulcer, GI
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/29
|
1.7%
1/60 • Number of events 1
|
Other adverse events
| Measure |
Arm 1, Gemcitabine and Cisplatin
n=29 participants at risk
Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
|
Arm 2, Cetuximab, Gemcitabine and Cisplatin
n=60 participants at risk
Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
|
|---|---|---|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
27.6%
8/29 • Number of events 12
|
21.7%
13/60 • Number of events 41
|
|
Metabolism and nutrition disorders
Anorexia
|
51.7%
15/29 • Number of events 18
|
45.0%
27/60 • Number of events 44
|
|
Gastrointestinal disorders
Constipation
|
48.3%
14/29 • Number of events 23
|
36.7%
22/60 • Number of events 35
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.1%
7/29 • Number of events 7
|
20.0%
12/60 • Number of events 19
|
|
Investigations
Creatinine
|
34.5%
10/29 • Number of events 39
|
26.7%
16/60 • Number of events 40
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29
|
25.0%
15/60 • Number of events 19
|
|
Gastrointestinal disorders
Diarrhea
|
31.0%
9/29 • Number of events 15
|
33.3%
20/60 • Number of events 42
|
|
Nervous system disorders
Dizziness
|
17.2%
5/29 • Number of events 6
|
26.7%
16/60 • Number of events 32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.7%
6/29 • Number of events 10
|
20.0%
12/60 • Number of events 16
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
79.3%
23/29 • Number of events 67
|
85.0%
51/60 • Number of events 146
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
44.8%
13/29 • Number of events 43
|
33.3%
20/60 • Number of events 96
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
17.2%
5/29 • Number of events 5
|
21.7%
13/60 • Number of events 13
|
|
Blood and lymphatic system disorders
Anemia
|
75.9%
22/29 • Number of events 54
|
61.7%
37/60 • Number of events 139
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
37.9%
11/29 • Number of events 13
|
46.7%
28/60 • Number of events 31
|
|
Investigations
Leukocytes (total WBC)
|
41.4%
12/29 • Number of events 30
|
51.7%
31/60 • Number of events 114
|
|
Investigations
Lymphopenia
|
20.7%
6/29 • Number of events 17
|
31.7%
19/60 • Number of events 100
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
20.7%
6/29 • Number of events 18
|
51.7%
31/60 • Number of events 132
|
|
Nervous system disorders
Mood alteration
|
24.1%
7/29 • Number of events 9
|
21.7%
13/60 • Number of events 20
|
|
Gastrointestinal disorders
Nausea
|
58.6%
17/29 • Number of events 43
|
63.3%
38/60 • Number of events 71
|
|
Nervous system disorders
Neuropathy: sensory
|
27.6%
8/29 • Number of events 10
|
26.7%
16/60 • Number of events 22
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
62.1%
18/29 • Number of events 44
|
60.0%
36/60 • Number of events 100
|
|
General disorders
Pain
|
100.0%
29/29 • Number of events 46
|
100.0%
60/60 • Number of events 136
|
|
General disorders
Pain - Other
|
20.7%
6/29 • Number of events 7
|
13.3%
8/60 • Number of events 12
|
|
Investigations
Platelets
|
89.7%
26/29 • Number of events 96
|
75.0%
45/60 • Number of events 162
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
24.1%
7/29 • Number of events 15
|
18.3%
11/60 • Number of events 32
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/29
|
35.0%
21/60 • Number of events 49
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
31.0%
9/29 • Number of events 11
|
23.3%
14/60 • Number of events 19
|
|
Ear and labyrinth disorders
Tinnitus
|
17.2%
5/29 • Number of events 6
|
0.00%
0/60
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
17.2%
5/29 • Number of events 8
|
0.00%
0/60
|
|
Gastrointestinal disorders
Vomiting
|
27.6%
8/29 • Number of events 14
|
33.3%
20/60 • Number of events 29
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/29
|
20.0%
12/60 • Number of events 36
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/29
|
18.3%
11/60 • Number of events 38
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/29
|
13.3%
8/60 • Number of events 22
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/29
|
8.3%
5/60 • Number of events 5
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
0.00%
0/29
|
10.0%
6/60 • Number of events 9
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/29
|
18.3%
11/60 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify)
|
0.00%
0/29
|
16.7%
10/60 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/29
|
26.7%
16/60 • Number of events 22
|
|
General disorders
Edema: limb
|
0.00%
0/29
|
26.7%
16/60 • Number of events 22
|
|
General disorders
Fever (in the absence of neutropenia)
|
0.00%
0/29
|
20.0%
12/60 • Number of events 18
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/29
|
25.0%
15/60 • Number of events 22
|
|
Renal and urinary disorders
Hemorrhage, GU
|
0.00%
0/29
|
13.3%
8/60 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
0.00%
0/29
|
8.3%
5/60 • Number of events 7
|
|
Cardiac disorders
Hypertension
|
0.00%
0/29
|
10.0%
6/60 • Number of events 9
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
0.00%
0/29
|
13.3%
8/60 • Number of events 8
|
|
Infections and infestations
Infection - Other
|
0.00%
0/29
|
10.0%
6/60 • Number of events 8
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/29
|
16.7%
10/60 • Number of events 11
|
|
Nervous system disorders
Insomnia
|
0.00%
0/29
|
10.0%
6/60 • Number of events 6
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
0.00%
0/29
|
10.0%
6/60 • Number of events 18
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
0.00%
0/29
|
15.0%
9/60 • Number of events 11
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
0.00%
0/29
|
11.7%
7/60 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
0.00%
0/29
|
11.7%
7/60 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/29
|
10.0%
6/60 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/29
|
18.3%
11/60 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/29
|
45.0%
27/60 • Number of events 85
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/29
|
55.0%
33/60 • Number of events 118
|
|
General disorders
Rigors/chills
|
0.00%
0/29
|
15.0%
9/60 • Number of events 12
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
0.00%
0/29
|
8.3%
5/60 • Number of events 9
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
0.00%
0/29
|
15.0%
9/60 • Number of events 11
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/29
|
13.3%
8/60 • Number of events 9
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/29
|
15.0%
9/60 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/29
|
8.3%
5/60 • Number of events 6
|
|
Investigations
Weight loss
|
0.00%
0/29
|
18.3%
11/60 • Number of events 14
|
Additional Information
Dr. Maha Hussain, M.D.
University of Michigan Comprehensive Cancer Center
Phone: (734) 647-8903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place