NCT01051362

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	PLD and Carboplatin	Pegylated liposomal doxorubicin (PLD) 30 mg/m2, followed by Carboplatin AUC (area under the curve) 5, every 21 days for 4 cycles or until progression.

Timeline

• Start date: 2006-02-01
• Primary completion: 2011-02-01
• Completion: 2011-11-01
• First posted: 2010-01-18
• Last updated: 2010-01-18

Locations

1 site across 1 country: China