Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00660504

Recruitment Status : Completed

First Posted : April 17, 2008

Results First Posted : July 4, 2014

Last Update Posted : July 18, 2014

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Sponsor:

Information provided by (Responsible Party):

Sumitomo Pharma (Suzhou) Co., Ltd.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Lung Cancer
Interventions	Drug: Amrubicin Hydrochloride Drug: Etoposide-Cisplatin combined chemotherapy
Enrollment	300

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
Arm/Group Description	Amrubicin Hydrochloride-Cisplatin c...	Etoposide-Cisplatin combined chemot...
Arm/Group Description	Amrubicin Hydrochloride-Cisplatin combined chemotherapy Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin	Etoposide-Cisplatin combined chemotherapy Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
Period Title: Overall Study
Started	149	151
Completed	149	150
Not Completed	0	1

Baseline Characteristics

Arm/Group Title		Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection	Total
Arm/Group Description		[Not Specified]	[Not Specified]	Total of all reporting groups
Arm/Group Description		[Not Specified]	[Not Specified]	Total of all reporting groups
Overall Number of Baseline Participants		149	150	299
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	149 participants	150 participants	299 participants
		56.1 (10.03)	57.45 (9.78)	56.78 (9.92)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	149 participants	150 participants	299 participants
	Female	35 23.5%	37 24.7%	72 24.1%
	Male	114 76.5%	113 75.3%	227 75.9%
Region of Enrollment Measure Type: Number Unit of measure: Participants
China	Number Analyzed	149 participants	150 participants	299 participants
China		149	150	299

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	[Not Specified]
Description	[Not Specified]
Time Frame	1.5 years after last subject enrolled

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
Arm/Group Description:	Amrubicin Hydrochloride-Cisplatin c...	Etoposide-Cisplatin combined chemot...
Arm/Group Description:	Amrubicin Hydrochloride-Cisplatin combined chemotherapy Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin	Etoposide-Cisplatin combined chemotherapy Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
Overall Number of Participants Analyzed	149	150
Median (95% Confidence Interval) Unit of Measure: month
	11.79 (11.01 to 12.62)	10.28 (9.23 to 11.96)

2.Secondary Outcome


Title	Progression-Free Survival
Description	[Not Specified]
Description	[Not Specified]
Time Frame	1.5 years after last subject enrolled

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
Arm/Group Description:	Amrubicin Hydrochloride-Cisplatin c...	Etoposide-Cisplatin combined chemot...
Arm/Group Description:	Amrubicin Hydrochloride-Cisplatin combined chemotherapy Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin	Etoposide-Cisplatin combined chemotherapy Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
Overall Number of Participants Analyzed	149	150
Median (95% Confidence Interval) Unit of Measure: month
	6.83 (6.11 to 7.39)	5.72 (5.06 to 6.93)

3.Secondary Outcome


Title	Objective Response Rate
Description	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0...
Description	Per 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.
Time Frame	participants were followed for the duration of the study, an average of 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
Arm/Group Description:	Amrubicin Hydrochloride-Cisplatin c...	Etoposide-Cisplatin combined chemot...
Arm/Group Description:	Amrubicin Hydrochloride-Cisplatin combined chemotherapy Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin	Etoposide-Cisplatin combined chemotherapy Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
Overall Number of Participants Analyzed	149	150
Measure Type: Number Unit of Measure: percentage of participants
	69.80	57.33

4.Other Pre-specified Outcome


Title	Overall Survival at 6 and 12 Months
Description	[Not Specified]
Description	[Not Specified]
Time Frame	6 and 12 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
Arm/Group Description:	Amrubicin Hydrochloride-Cisplatin c...	Etoposide-Cisplatin combined chemot...
Arm/Group Description:	Amrubicin Hydrochloride-Cisplatin combined chemotherapy Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin	Etoposide-Cisplatin combined chemotherapy Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
Overall Number of Participants Analyzed	149	150
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of patients
6-month	89.26 (83.07 to 93.28)	86.00 (79.34 to 90.64)
12-month	48.59 (40.31 to 56.36)	41.93 (33.97 to 49.68)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection
Arm/Group Description	[Not Specified]	[Not Specified]
Arm/Group Description	[Not Specified]	[Not Specified]
All-Cause Mortality
	Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection
	Affected / at Risk (%)	Affected / at Risk (%)
Total	21/149 (14.09%)	8/150 (5.33%)
Blood and lymphatic system disorders
Anemia ^† 1	0/149 (0.00%)	1/150 (0.67%)
Agranulocytosis ^† 1	1/149 (0.67%)	0/150 (0.00%)
Febrile neutropenia syndrome ^† 1	3/149 (2.01%)	0/150 (0.00%)
Bone marrow failure ^† 1	5/149 (3.36%)	3/150 (2.00%)
Cardiac disorders
Supraventricular tachycardia ^† 1	1/149 (0.67%)	0/150 (0.00%)
Ventricular arrhythmias ^† 1	1/149 (0.67%)	0/150 (0.00%)
Gastrointestinal disorders
Diarrhea ^† 1	2/149 (1.34%)	0/150 (0.00%)
Gastrointestinal Disorders ^† 1	1/149 (0.67%)	0/150 (0.00%)
Infections and infestations
fever ^† 1	2/149 (1.34%)	0/150 (0.00%)
Bronchitis ^† 1	0/149 (0.00%)	1/150 (0.67%)
Investigations
Lower hemoglobin ^† 1	1/149 (0.67%)	0/150 (0.00%)
Neutrophil count decreased ^† 1	7/149 (4.70%)	0/150 (0.00%)
Platelet count decreased ^† 1	3/149 (2.01%)	1/150 (0.67%)
White blood cell count decreased ^† 1	6/149 (4.03%)	0/150 (0.00%)
Metabolism and nutrition disorders
Hypokalemia ^† 1	2/149 (1.34%)	0/150 (0.00%)
Nervous system disorders
Cerebral infarction ^† 1	1/149 (0.67%)	2/150 (1.33%)
Dyskinesia ^† 1	0/149 (0.00%)	1/150 (0.67%)
Speech disorder ^† 1	0/149 (0.00%)	1/150 (0.67%)
Spinal cord compression ^† 1	0/149 (0.00%)	1/150 (0.67%)
Psychiatric disorders
Mental disorders ^† 1	1/149 (0.67%)	0/150 (0.00%)
Renal and urinary disorders
Acute renal failure ^† 1	1/149 (0.67%)	0/150 (0.00%)
Vascular disorders
Chronic cholecystitis ^† 1	1/149 (0.67%)	0/150 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 14.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection
	Affected / at Risk (%)	Affected / at Risk (%)
Total	149/149 (100.00%)	148/150 (98.67%)
Blood and lymphatic system disorders
Neutrophil count decreased ^* 1	99/149 (66.44%)	85/150 (56.67%)
White blood cell count decreased ^* 1	97/149 (65.10%)	85/150 (56.67%)
Platelet count decreased ^* 1	54/149 (36.24%)	40/150 (26.67%)
Lower hemoglobin ^* 1	49/149 (32.89%)	50/150 (33.33%)
Anemia ^* 1	48/149 (32.21%)	48/150 (32.00%)
Bone marrow failure ^* 1	46/149 (30.87%)	46/150 (30.67%)
Decreased red blood cell count ^* 1	14/149 (9.40%)	15/150 (10.00%)
Gastrointestinal disorders
Nausea ^† 1	72/149 (48.32%)	70/150 (46.67%)
vomit ^* 1	63/149 (42.28%)	63/150 (42.00%)
Decreased appetite ^* 1	60/149 (40.27%)	50/150 (33.33%)
Constipation ^* 1	32/149 (21.48%)	25/150 (16.67%)
Diarrhea ^* 1	25/149 (16.78%)	13/150 (8.67%)
Gastrointestinal Disorders ^* 1	22/149 (14.77%)	26/150 (17.33%)
Mouth ulcers ^* 1	9/149 (6.04%)	6/150 (4.00%)
General disorders
Alopecia ^* 1	31/149 (20.81%)	20/150 (13.33%)
Fatigue ^* 1	27/149 (18.12%)	11/150 (7.33%)
alanine aminotransferase increased ^* 1	9/149 (6.04%)	6/150 (4.00%)
Hepatobiliary disorders
Abnormal liver function ^* 1	8/149 (5.37%)	5/150 (3.33%)
Infections and infestations
fever ^* 1	28/149 (18.79%)	12/150 (8.00%)
Investigations
Lymphocyte count decreased ^* 1	13/149 (8.72%)	5/150 (3.33%)
Reduced red blood cell count ^* 1	14/149 (9.40%)	15/150 (10.00%)
Metabolism and nutrition disorders
Hypocalcemia ^* 1	8/149 (5.37%)	4/150 (2.67%)
Hypochloraemia ^* 1	9/149 (6.04%)	2/150 (1.33%)
Hypokalemia ^* 1	13/149 (8.72%)	6/150 (4.00%)
Hyponatremia ^* 1	12/149 (8.05%)	5/150 (3.33%)
Nervous system disorders
Dizziness ^* 1	10/149 (6.71%)	6/150 (4.00%)
Headache ^* 1	9/149 (6.04%)	1/150 (0.67%)
Psychiatric disorders
Insomnia ^* 1	11/149 (7.38%)	7/150 (4.67%)
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	10/149 (6.71%)	4/150 (2.67%)
Hemoptysis ^* 1	9/149 (6.04%)	3/150 (2.00%)
Hiccup ^* 1	8/149 (5.37%)	10/150 (6.67%)
† Indicates events were collected by systematic assessment * Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 14.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr.Sunyan
Organization:	Cancer Hospital of Chinese Academy of Medical Sciences
Phone:	86-10-87788519
EMail:	suny@csco.org.cn

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6.

Layout table for additonal information

Responsible Party:	Sumitomo Pharma (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00660504
Other Study ID Numbers:	D0750018 D0750018
First Submitted:	April 10, 2008
First Posted:	April 17, 2008
Results First Submitted:	November 21, 2013
Results First Posted:	July 4, 2014
Last Update Posted:	July 18, 2014

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