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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Sumitomo Pharmaceutical (Suzhou) Co., Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00660504
First received: April 10, 2008
Last updated: August 5, 2010
Last verified: August 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
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: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
 Drug: Amrubicin Hydrochloride
Amrubicin Hydrochloride combined with cisplatin
Active Comparator: 2
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

Locations
China, Fujian
Fuzhou, Fujian, China
China, Gansu
Lanzhou, Gansu, China
China, Guangdong
Guangzhou, Guangdong, China
China, Hunan
Changsha, Hunan, China
China, Jiangsu
Nanjing, Jiangsu, China
China, Jiangxi
Nanchang, Jiangxi, China
China, Jilin
Changchun, Jilin, China
China, Liaoning
Dalian/Shenyang, Liaoning, China
Shenyang, Liaoning, China
China, Shanxi
Xian, Shanxi, China
China, Sichuan
Chengdu, Sichuan, China
China, Zhejiang
Hangzhou, Zhejiang, China
China
Beijing, China
Shanghai, China
Tianjin, 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: Xiao-yan Luo, The medical department head of Sumitomo Pharmaceutical (Suzhou) Co., Ltd, Sumitomo Pharmaceutical (Suzhou) Co., Ltd
ClinicalTrials.gov Identifier: NCT00660504     History of Changes
Other Study ID Numbers: D0750018, D0750018
Study First Received: April 10, 2008
Last Updated: August 5, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:
Extensive Disease-Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Etoposide phosphate
Amrubicin
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013