NSCLC Clinical Trial
Official title:
First Line Treatment of Elderly Patients With Advanced or Metastatic NSCLC With Docetaxel and Bevacizumab
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
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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