NCT00193362

Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer

Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness of the three-drug combination paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and vinorelbine in patients with advanced Non-Small Cell Lung Cancer

Detailed description

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * Paclitaxel + Carboplatin + Gemcitabine * Gemcitabine + Vinorelbine For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel
DRUG	Carboplatin
DRUG	Gemcitabine
DRUG	Vinorelbine

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-06-01
• Completion: 2007-09-01
• First posted: 2005-09-19
• Last updated: 2010-07-28