Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Lung Cancer

Treatments: Drug: Etoposide-Cisplatin combined chemotherapy; Drug: Amrubicin Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00660504

D0750018

Details and patient eligibility

About

This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically/cytologically proven small cell lung cancer
• Extensive disease
• No prior chemotherapy regimen
• Age 18 years or older
• ECOG performance status of 0-1

Exclusion criteria

• Brain metastasis requiring treatment
• Treatment (Surgical or radiotherapy)of primary tumor
• Interstitial pneumonia or pulmonary fibrosis
• Abnormal cardiac function or myocardial infraction within 6 months before study enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1

Experimental group

Description:

Amrubicin Hydrochloride-Cisplatin combined chemotherapy

Treatment:

Drug: Amrubicin Hydrochloride

2

Active Comparator group

Description:

Etoposide-Cisplatin combined chemotherapy

Treatment:

Drug: Etoposide-Cisplatin combined chemotherapy