The purpose of this study is to evaluate the efficacy and toxicity of combination of erlotinib and bevacizumab in patients with locally advanced or metastatic, non-squamous non-small cell lung cancer, who progressed after first line treatment. Pretreatment with one of the two agents would not excluded patients from the study, in order to evaluate whether the combination of the two biologic agents could reverse tumor resistance.
A randomized, placebo-controlled phase III trial of erlotinib versus placebo, demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Moreover, the addition of bevacizumab, a monoclonal antibody against Vascular Endothelial Growth Factor bevacizumab (VEGF), to systemic chemotherapy, improved both the response rates and the time to tumor progression in two trials. Early data from phase I/II trials examining the combination of these two biological agents in pre-treated patients with non-squamous NSCLC, showed no major pharmacokinetic interactions and promising clinical activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Erlotinib 150mg daily, continuously, until disease progression or the appearance of unacceptable toxicity
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression or the appearance of unacceptable toxicity
University Hospital of Heraklion
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
Overall response rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and
Progression Free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year
Quality of life assessment
Time frame: Assessment every two cycles
Toxicity profile
Time frame: Assessment every two cycles
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401 Military Hospital, Medical Oncology Unit
Athens, Greece
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens, Greece
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus, Greece
Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki, Greece