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Pegylated Liposomal Doxorubicin and Carboplatin as First Line Treatment for Patients With Advanced Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:
Phase II Study of Pegylated Liposomal Doxorubicin and Carboplatin as First Line Treatment for Patients With Advanced Non-small Cell Lung Cancer

Clinical Trial Summary

This Phase II study is to explore the efficacy and toxicity of Pegylated liposomal doxorubicin and Carboplatin in patients with previously untreated non-small cell lung cancer (NSCLC) not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 48 patients (including a 10% rate for inevaluable patients).

Clinical Trial Description

Pegylated liposomal doxorubicin (PLD) is the first antineoplastic drug derived from the new technology of liposome formulation to be introduced in clinical practice. The low myocardium uptake of this formulation accounts for its reduced cardiac toxicity, confirmed both in preclinical models and in humans. Preclinical data have shown activity in NSCLC xenografts. This Phase II study is to explore the efficacy and toxicity of Pegylated liposomal doxorubicin and Carboplatin in patients with previously untreated non-small cell lung cancer (NSCLC) not amenable to radiotherapy or surgical treatment. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01051362
Study type Interventional
Source The First Affiliated Hospital of Guangzhou Medical University
Contact Wenlong Shao, MD
Phone +86-20-83337750
Email myfriends2003@126.com
Status Recruiting
Phase Phase 2
Start date February 2006
Completion date November 2011
View Details
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