A Phase II Study of the Combination of Metronomic Docetaxel and Bevacizumab as 2nd Line Treatment in Patients With Small Cell Lung Cancer (SCLC)
Approximately 80% of the patients with localized SCLC and all of the patients with extensive
SCLC will relapse after 1st line chemotherapy. For the chemo-resistant patients (eg those
that have relapsed during or less than 3 months after 1st line chemotherapy the sole agent
approved for 2nd line chemotherapy is topotecan. Docetaxel has shown some activity as 1st
line treatment (ORR 17%). The low dose metronomic chemotherapy that is administered in short
intervals has been shown in vitro an in vivo to have antiangiogenic effects. Bevacizumab is
a well known anti-angiogenic agent. Recently, a phase III study of 1st line treatment in
patients with advanced or metastatic NSCLC showed that the addition of bevacizumab to a
platinum-based regimen provided a survival benefit. A number of phase II studies are
currently evaluating the addition of bevacizumab to 1st line chemotherapy in SCLC patients
with promising results of safety and efficacy. Given the poor results of 2nd line
chemotherapy in SCLC we feel that the evaluation of the combination of metronomic docetaxel
and bevacizumab (2 anti-angiogenic agents) in such patients is justified. This study will
evaluate the combination of metronomic docetaxel and bevacizumab as 2nd line treatment of
SCLC.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
up to 6 months
No
Sofia Agelaki, MD
Principal Investigator
University Hospital of Crete, Dep of Medical Oncology
Greece: National Organization of Medicines
CT/08.06
NCT00755157
April 2008
December 2012
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