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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Treatments: Amrubicin; Cisplatin; Etoposide; Etoposide phosphate

Criteria

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