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

This study has been terminated.

Sponsor:

Information provided by:

Sumitomo Dainippon Pharma Co., Ltd.

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 Sumitomo Dainippon Pharma Co., Ltd.:

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sumitomo Dainippon Pharma Co., Ltd.

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 Sumitomo Dainippon Pharma Co., Ltd.:


Extensive-disease small-cell lung cancer (ED-SCLC)

Additional relevant MeSH terms:


Lung Neoplasms Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site	Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Amrubicin Antineoplastic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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