NCT02179567

Docetaxel Plus Bevacizumab for Elderly Patients With Stage IV NSCLC

First Line Treatment of Elderly Patients With Advanced or Metastatic NSCLC With Docetaxel and Bevacizumab

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to study the efficacy and safety of the combination of Docetaxel plus Bevacizumab in a Phase II trial of elderly subjects with non-small cell lung cancer

Detailed description

About 50% of newly diagnosed cases of NSCLC concern patients older than 65 years, while 30-40% of cases are diagnosed in patients older than 70 years. Furthermore, recent data suggest that during the last decade, the incidence and mortality of NSCLC has decreased in younger patients, while it has increased among older patients. Based on these observations, it becomes clear that NSCLC represents a significant health problem in elderly patients. However, elderly patients are frequently underrepresented in clinical trials evaluating new treatments in NSCLC. Indeed, more than 75% of patients older than 65 years with metastatic NSCLC never receive any kind of chemotherapy in the daily clinical practice. According to retrospective data,the addition of bevacizumab to a standard, platinum-based chemotherapy regimen improves overall survival in patients with advanced non-squamous-cell, non-small-cell lung cancer and a good ECOG performance status. In addition, bevacizumab prolongs progression-free survival and improves response rate. In elderly patients there is a complete lack of prospective data regarding the role of bevacizumab. It is not clear whether elderly patients gain any survival benefit or not and if the addition of bevacizumab to standard chemotherapeutic regimens results in a significant increase in toxicity. There is a clear need to prospectively evaluate the tolerability of bevacizumab when added to standard first-line chemotherapy of elderly NSCLC patients. Therefore, the investigators propose to study the efficacy in elderly (\>70 years) patients treated with cytotoxic chemotherapy in combination with bevacizumab in the context of 1st line treatment.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel: 60mg/m2 i.v on day 1. Cycle repeated ever 3 weeks
DRUG	Bevacizumab	Bevacizumab: 7.5 mg/kg, iv on day 1. Cycle repeated every 3 weeks

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2014-07-02
• Last updated: 2015-09-28

Locations

5 sites across 1 country: Greece