Trial Outcomes & Findings for Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer (NCT NCT00660504)
NCT ID: NCT00660504
Last Updated: 2014-07-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
1.5 years after last subject enrolled
Results posted on
2014-07-18
Participant Flow
Participant milestones
| Measure |
Amrubicin Combined With Cisplatin Group
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin
|
Etoposide Combined With Cisplatin Group
Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
151
|
|
Overall Study
COMPLETED
|
149
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Amrubicin, Anticancer, Injection
n=149 Participants
|
Etoposide, Anticancer, Injection
n=150 Participants
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 10.03 • n=5 Participants
|
57.45 years
STANDARD_DEVIATION 9.78 • n=7 Participants
|
56.78 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
149 participants
n=5 Participants
|
150 participants
n=7 Participants
|
299 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.5 years after last subject enrolledOutcome measures
| Measure |
Amrubicin Combined With Cisplatin Group
n=149 Participants
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin
|
Etoposide Combined With Cisplatin Group
n=150 Participants
Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
|
|---|---|---|
|
Overall Survival
|
11.79 month
Interval 11.01 to 12.62
|
10.28 month
Interval 9.23 to 11.96
|
SECONDARY outcome
Timeframe: 1.5 years after last subject enrolledOutcome measures
| Measure |
Amrubicin Combined With Cisplatin Group
n=149 Participants
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin
|
Etoposide Combined With Cisplatin Group
n=150 Participants
Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
|
|---|---|---|
|
Progression-Free Survival
|
6.83 month
Interval 6.11 to 7.39
|
5.72 month
Interval 5.06 to 6.93
|
SECONDARY outcome
Timeframe: participants were followed for the duration of the study, an average of 12 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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 (OR) = CR + PR.
Outcome measures
| Measure |
Amrubicin Combined With Cisplatin Group
n=149 Participants
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin
|
Etoposide Combined With Cisplatin Group
n=150 Participants
Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
|
|---|---|---|
|
Objective Response Rate
|
69.80 percentage of participants
|
57.33 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 months.Outcome measures
| Measure |
Amrubicin Combined With Cisplatin Group
n=149 Participants
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin
|
Etoposide Combined With Cisplatin Group
n=150 Participants
Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
|
|---|---|---|
|
Overall Survival at 6 and 12 Months
6-month
|
89.26 percentage of patients
Interval 83.07 to 93.28
|
86.00 percentage of patients
Interval 79.34 to 90.64
|
|
Overall Survival at 6 and 12 Months
12-month
|
48.59 percentage of patients
Interval 40.31 to 56.36
|
41.93 percentage of patients
Interval 33.97 to 49.68
|
Adverse Events
Amrubicin, Anticancer, Injection
Serious events: 21 serious events
Other events: 149 other events
Deaths: 0 deaths
Etoposide, Anticancer, Injection
Serious events: 8 serious events
Other events: 148 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amrubicin, Anticancer, Injection
n=149 participants at risk
|
Etoposide, Anticancer, Injection
n=150 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/149
|
0.67%
1/150
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.67%
1/149
|
0.00%
0/150
|
|
Blood and lymphatic system disorders
Febrile neutropenia syndrome
|
2.0%
3/149
|
0.00%
0/150
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
3.4%
5/149
|
2.0%
3/150
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.67%
1/149
|
0.00%
0/150
|
|
Cardiac disorders
Ventricular arrhythmias
|
0.67%
1/149
|
0.00%
0/150
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
2/149
|
0.00%
0/150
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
0.67%
1/149
|
0.00%
0/150
|
|
Infections and infestations
fever
|
1.3%
2/149
|
0.00%
0/150
|
|
Vascular disorders
Chronic cholecystitis
|
0.67%
1/149
|
0.00%
0/150
|
|
Infections and infestations
Bronchitis
|
0.00%
0/149
|
0.67%
1/150
|
|
Investigations
Lower hemoglobin
|
0.67%
1/149
|
0.00%
0/150
|
|
Investigations
Neutrophil count decreased
|
4.7%
7/149
|
0.00%
0/150
|
|
Investigations
Platelet count decreased
|
2.0%
3/149
|
0.67%
1/150
|
|
Investigations
White blood cell count decreased
|
4.0%
6/149
|
0.00%
0/150
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.3%
2/149
|
0.00%
0/150
|
|
Nervous system disorders
Cerebral infarction
|
0.67%
1/149
|
1.3%
2/150
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/149
|
0.67%
1/150
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/149
|
0.67%
1/150
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/149
|
0.67%
1/150
|
|
Renal and urinary disorders
Acute renal failure
|
0.67%
1/149
|
0.00%
0/150
|
|
Psychiatric disorders
Mental disorders
|
0.67%
1/149
|
0.00%
0/150
|
Other adverse events
| Measure |
Amrubicin, Anticancer, Injection
n=149 participants at risk
|
Etoposide, Anticancer, Injection
n=150 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
48.3%
72/149
|
46.7%
70/150
|
|
Gastrointestinal disorders
vomit
|
42.3%
63/149
|
42.0%
63/150
|
|
Gastrointestinal disorders
Decreased appetite
|
40.3%
60/149
|
33.3%
50/150
|
|
Gastrointestinal disorders
Constipation
|
21.5%
32/149
|
16.7%
25/150
|
|
General disorders
Alopecia
|
20.8%
31/149
|
13.3%
20/150
|
|
Infections and infestations
fever
|
18.8%
28/149
|
8.0%
12/150
|
|
General disorders
Fatigue
|
18.1%
27/149
|
7.3%
11/150
|
|
Gastrointestinal disorders
Diarrhea
|
16.8%
25/149
|
8.7%
13/150
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
14.8%
22/149
|
17.3%
26/150
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
66.4%
99/149
|
56.7%
85/150
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
65.1%
97/149
|
56.7%
85/150
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
36.2%
54/149
|
26.7%
40/150
|
|
Blood and lymphatic system disorders
Lower hemoglobin
|
32.9%
49/149
|
33.3%
50/150
|
|
Blood and lymphatic system disorders
Anemia
|
32.2%
48/149
|
32.0%
48/150
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
30.9%
46/149
|
30.7%
46/150
|
|
Blood and lymphatic system disorders
Decreased red blood cell count
|
9.4%
14/149
|
10.0%
15/150
|
|
Gastrointestinal disorders
Mouth ulcers
|
6.0%
9/149
|
4.0%
6/150
|
|
Hepatobiliary disorders
Abnormal liver function
|
5.4%
8/149
|
3.3%
5/150
|
|
Investigations
Lymphocyte count decreased
|
8.7%
13/149
|
3.3%
5/150
|
|
Investigations
Reduced red blood cell count
|
9.4%
14/149
|
10.0%
15/150
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.4%
8/149
|
2.7%
4/150
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
6.0%
9/149
|
1.3%
2/150
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.7%
13/149
|
4.0%
6/150
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.1%
12/149
|
3.3%
5/150
|
|
Nervous system disorders
Dizziness
|
6.7%
10/149
|
4.0%
6/150
|
|
Nervous system disorders
Headache
|
6.0%
9/149
|
0.67%
1/150
|
|
Psychiatric disorders
Insomnia
|
7.4%
11/149
|
4.7%
7/150
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
10/149
|
2.7%
4/150
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.0%
9/149
|
2.0%
3/150
|
|
Respiratory, thoracic and mediastinal disorders
Hiccup
|
5.4%
8/149
|
6.7%
10/150
|
|
General disorders
alanine aminotransferase increased
|
6.0%
9/149
|
4.0%
6/150
|
Additional Information
Dr.Sunyan
Cancer Hospital of Chinese Academy of Medical Sciences
Phone: 86-10-87788519
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60