NCT00345059

The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.

Detailed description

This study is for patients with previously diagnosed advanced non small cell lung cancer (NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens: * docetaxel * docetaxel + vinorelbine * docetaxel + gemcitabine * docetaxel + capecitabine

Conditions

• Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	vinorelbine
DRUG	gemcitabine
DRUG	capecitabine

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2006-06-27
• Last updated: 2016-01-14

Locations

24 sites across 1 country: Italy