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NCT00286169 Clinical Trial

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

Small-cell Lung Cancer Clinical Trial

Official title:
Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00286169
Other study ID # D0702002
Secondary ID JapicCTI-060203
Status Terminated
Phase Phase 3
First received
Last updated
Start date April 2006

Study information
Verified date April 2022
Source Sumitomo Pharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 130
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amrubicin Hydrochloride

Locations
Country Name City State
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

Sponsors (1)
Lead Sponsor Collaborator
Sumitomo Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival
Secondary Time to progression
Secondary Objective tumor response
Secondary Quality of Life (QOL: EuroQOL, FACT-L-LCS)
Secondary Frequency and severity of adverse events
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