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

This study has been terminated.
Sponsor:
Information provided by:
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT00286169
First received: February 1, 2006
Last updated: August 9, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Small-cell Lung Cancer
 Drug: Amrubicin Hydrochloride
 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 Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Dainippon Sumitomo Pharma:

Primary Outcome Measures:
  • Overall survival

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

Estimated Enrollment: 130
Study Start Date: April 2006
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286169

Locations
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
Dainippon Sumitomo Pharma
Investigators
Study Director: Drug Development Division Dainippon Sumitomo Pharma Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00286169     History of Changes
Other Study ID Numbers: D0702002, JapicCTI-060203
Study First Received: February 1, 2006
Last Updated: August 9, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Dainippon Sumitomo Pharma:
Extensive-disease small-cell lung cancer (ED-SCLC)

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
Amrubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013