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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Active 18 and over Other D0750018
D0750018, NCT00660504

Trial Description

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

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Yan Sun, MD

Principal Investigator

Xiao-yan Luo, MD

Ph: +861066425188 Ext.25

Trial Sites

China

Beijing

Study Site

Nanchang

Study Site

Shanghai

Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00660504
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.