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Brief Title: Metronomic Docetaxel and Bevacizumab in Patients With Small Cell Lung Cancer
Official Title: A Phase II Study of the Combination of Metronomic Docetaxel and Bevacizumab as 2nd Line Treatment in Patients With Small Cell Lung Cancer (SCLC)
Study ID: NCT00755157
Brief Summary: This trial will evaluate the efficacy and safety of metronomic docetaxel and bevacizumab combination in patients with pretreated, advanced small cell lung cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital of Crete, Dep of Medical Oncology, Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, , Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, , Greece
Name: Sofia Agelaki, MD
Affiliation: University Hospital of Crete, Dep of Medical Oncology
Role: PRINCIPAL_INVESTIGATOR