Neuroendocrine Carcinomas Clinical Trial
Official title:
Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors
Well differentiated neuroendocrine (NE) carcinomas have low proliferative activity and conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties. Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing metronomic chemotherapy and antiangiogenetic drugs. This is a national, multicenter, phase II study.
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
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