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Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)

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ClinicalTrials.gov Identifier: NCT00286169
Recruitment Status : Terminated
First Posted : February 3, 2006
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
Sumitomo Dainippon Pharma Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.

Condition or disease Intervention/treatment Phase
Small-cell Lung Cancer Drug: Amrubicin Hydrochloride Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer
Study Start Date : April 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Time to progression
  2. Objective tumor response
  3. Quality of Life (QOL: EuroQOL, FACT-L-LCS)
  4. Frequency and severity of adverse events

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Extensive-disease small-cell lung cancer
  • Aged 70 years or older
  • Performance status of 0-2
  • No prior chemotherapy

Exclusion Criteria:

  • Prior therapy for primary lesion
  • Pneumonitis and/or pulmonary fibrosis
  • Active concomitant malignancy
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): NCT00286169


Locations
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Japan
Chubu Region Site
Chubu, Japan
Chugoku Region Site
Chugoku, Japan
Hokkaido Region Site
Hokkaido, Japan
Kanto Region Site
Kanto, Japan
Kinki Region Site
Kinki, Japan
Kyushu Region Site
Kyushu, Japan
Shikoku Region Site
Shikoku, Japan
Tohoku Region Site
Tohoku, Japan
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Investigators
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Study Director: Drug Development Division Dainippon Sumitomo Pharma Co., Ltd.
More Information
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ClinicalTrials.gov Identifier: NCT00286169    
Other Study ID Numbers: D0702002
JapicCTI-060203
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: August 10, 2010
Last Verified: August 2010
Keywords provided by Sumitomo Dainippon Pharma Co., Ltd.:
Extensive-disease small-cell lung cancer (ED-SCLC)
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Amrubicin
Antineoplastic Agents