A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy
- To determine the median time to progression (TTP) and response rate (RR) of the
combination of erlotinib and bevacizumab in patients with advanced upper
gastro-intestinal carcinomas, refractory or intolerant to standard systemic therapy.
- To determine safety, tolerability and toxicity.
- To determine median and overall survival (OS).
- To correlate efficacy of treatment with the expression of tumor markers obtained in
serum (EFGR, bFGF, p-VEGF-A, and sVEGF-R2), in paraffin embedded tumor tissue (micro
vessel density (MVD), and expression of VEGFR and EGFR, after immunostaining), and in
fresh frozen tumor biopsies (micro array-based analyses of patterns of gene
Bevacizumab (AvastinÒ) will be given intravenously at 10 mg/kg every other week.
Erlotinib is given as an orally daily dose and most be taken at least one hour before or two
hours after ingestion of food.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response by RECIST criteria
From time of treatment start to response evaluation
Ulrik Lassen, MD., PH.D.
Rigshospitalet, Dept. of Oncology
Denmark: Danish Medicines Agency