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

Sumitomo Pharma

Status and phase: Terminated; Phase 3

Conditions: Small-cell Lung Cancer

Treatments: Drug: Amrubicin Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00286169

JapicCTI-060203

D0702002

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)