NCT00620971

Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC

Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate whether the sequential administration of Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival advantage in patients with locally advanced or metastatic NSCLC.

Detailed description

An unanswered question in first line treatment of non small cell lung cancer (NSCLC) is whether the administration of more than 2 active drugs provides greater efficacy than a two-drug combination. Docetaxel/gemcitabine combination is a well tolerated regimen, which has comparable efficacy to docetaxel/cisplatin or vinorelbine/cisplatin. In a recent phase II study in first line treatment of advanced or metastatic NSCLC, the sequential administration of vinorelbine/cisplatin followed by docetaxel/gemcitabine produced a response rate of 45.8% and a 1-year survival rate of 51%. The addition of bevacizumab to a platinum-based regimen provided a survival benefit in patients with advanced or metastatic NSCLC.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Vinorelbine	Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles
DRUG	Cisplatin	Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
DRUG	Bevacizumab	Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
DRUG	Docetaxel	Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
DRUG	Gemcitabine	Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles
DRUG	Bevacizumab	Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
DRUG	Docetaxel	Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
DRUG	Cisplatin	Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
DRUG	Bevacizumab	Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-02-22
• Last updated: 2014-06-25

Locations

9 sites across 1 country: Greece