NCT00441740

Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 419 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.

Detailed description

Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a statistically significant difference in terms of time to tumor progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of these two doublets, would be interesting.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Vinorelbine	Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
DRUG	Gemcitabine	Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
DRUG	Docetaxel	Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles

Timeline

• Start date: 2004-04-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-03-01
• Last updated: 2008-10-31

Locations

9 sites across 1 country: Greece