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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00660504
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : July 4, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharma (Suzhou) Co., Ltd.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Drug: Amrubicin Hydrochloride Drug: Etoposide-Cisplatin combined chemotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 1.5 years after last subject enrolled ]

Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 1.5 years after last subject enrolled ]
  2. Objective Response Rate [ Time Frame: participants were followed for the duration of the study, an average of 12 weeks ]
    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.


Other Outcome Measures:
  1. Overall Survival at 6 and 12 Months [ Time Frame: 6 and 12 months. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660504


Locations
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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 Pharma (Suzhou) Co., Ltd.
Investigators
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Principal Investigator: Yan Sun, MD Cancer hospital, Chinese Academy of Medical Science
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sumitomo Pharma (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT00660504    
Other Study ID Numbers: D0750018
D0750018
First Posted: April 17, 2008    Key Record Dates
Results First Posted: July 4, 2014
Last Update Posted: July 18, 2014
Last Verified: July 2014
Keywords provided by Sumitomo Pharma (Suzhou) Co., Ltd.:
Extensive Disease-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Etoposide
 Amrubicin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action