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

This study is currently recruiting participants.

Verified by Sumitomo Pharmaceutical (Suzhou) Co., Ltd., August 2009

First Received: April 10, 2008 Last Updated: August 19, 2009 History of Changes

Sponsored by:	Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Information provided by:	Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00660504

Purpose

This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

Condition	Intervention	Phase
Lung Cancer	Drug: Amrubicin Hydrochloride Drug: Etoposide-Cisplatin combined chemotherapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Amrubicin Etoposide phosphate

U.S. FDA Resources

Further study details as provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:

Primary Outcome Measures:

Overall survival [ Time Frame: 1.5 years after last subject first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-Free survival; Objective response rate; Toxicity [ Time Frame: 1.5 years after last subject first visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Amrubicin Hydrochloride-Cisplatin combined chemotherapy	Drug: Amrubicin Hydrochloride Amrubicin Hydrochloride combined with cisplatin
2: Active Comparator Etoposide-Cisplatin combined chemotherapy	Drug: Etoposide-Cisplatin combined chemotherapy combined chemotherapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically/cytologically proven small cell lung cancer
Extensive disease
No prior chemotherapy regimen
Age 18 years or older
ECOG performance status of 0-1

Exclusion Criteria:

Brain metastasis requiring treatment
Treatment (Surgical or radiotherapy)of primary tumor
Interstitial pneumonia or pulmonary fibrosis
Abnormal cardiac function or myocardial infraction within 6 months before study enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660504

Contacts

Contact: Xiao-yan Luo, MD

+861066425188 ext 25

Locations

China
	Recruiting
Beijing, China
	Recruiting
Tianjin, China
	Recruiting
Shanghai, China
China, Fujian
	Recruiting
Fuzhou, Fujian, China
China, Gansu
	Recruiting
Lanzhou, Gansu, China
China, Guangdong
	Recruiting
Guangzhou, Guangdong, China
China, Hunan
	Recruiting
Changsha, Hunan, China
China, Jiangsu
	Recruiting
Nanjing, Jiangsu, China
China, Jiangxi
	Recruiting
Nanchang, Jiangxi, China
China, Jilin
	Recruiting
Changchun, Jilin, China
China, Liaoning
	Recruiting
Dalian/Shenyang, Liaoning, China
	Recruiting
Shenyang, Liaoning, China
China, Shanxi
	Recruiting
Xian, Shanxi, China
China, Sichuan
	Recruiting
Chengdu, Sichuan, China
China, Zhejiang
	Recruiting
Hangzhou, Zhejiang, China

Sponsors and Collaborators

Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Investigators

Principal Investigator:

Yan Sun, MD

Cancer hospital, Chinese Academy of Medical Science

More Information

No publications provided

Responsible Party:	Sumiyaku China Co., Ltd ( Xiao-yan Lou, The medical department head of Sumiyaku China )
Study ID Numbers:	D0750018, D0750018
Study First Received:	April 10, 2008
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00660504 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:

Extensive Disease-Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Amrubicin
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Radiation-Sensitizing Agents
Cisplatin

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Etoposide phosphate
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Amrubicin
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009