NCT00145418

Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer

Phase 2 Study Evaluating the Safety and Efficacy of Eloxatin (Oxaliplatin) and Docetaxel as First-line Therapy of Stage IV or IIIB Unresectable Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Oncology Specialists, S.C. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.

Detailed description

This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive: * oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15 * docetaxel 30mg/m2 on Days 1 and 8 Cycles are to be repeated every 28 days for a maximum of 6 cycles.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Oxaliplatin + Docetaxel	Oxaliplatin 85mg/m2 Docetaxel 30mg.m2

Timeline

• Start date: 2005-02-01
• Primary completion: 2009-08-01
• Completion: 2010-03-01
• First posted: 2005-09-05
• Last updated: 2014-06-30
• Results posted: 2013-01-31

Locations

1 site across 1 country: United States