Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors
Metastatic or locally advanced well differentiated neuroendocrine carcinoma will be treated
with a combination of bevacizumab (5 mg/kg) plus octreotide LAR (long- acting release) 20/30
mg plus capecitabine administered on a metronomic schedule (2000 mg/day).
Patients with stable disease, complete or partial response will continue treatment until
progressive disease or unacceptable toxicity.
Primary endpoint: the response to treatment, evaluated according to the RECIST criteria.
Secondary endpoint: - toxicity, graded according to the NCI-CTG criteria;
- symptomatic response: evaluated according to the changes in both the frequency and
intensity of symptoms;
- biochemical response: evaluated considering the changes in the tumor marker levels
(circulating Chromogranin A);
- relationship between vascular endothelial growth factor (VEGF) polymorphisms and
response to treatment;
- time to progression and survival: measured from the date of treatment start to the date
of progression and the date of last follow-up or death, respectively.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
time to progression
Alfredo Berruti, MD, PhD
Medical Oncology, Department of Clinical and Biological Sciences, University of Turin
Italy: AIFA - The Italian Medicines Agency