Neoplasms

All Conditions

Rare Diseases

Carcinoma

Neuroendocrine Tumors

Carcinoma, Neuroendocrine

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Capecitabine

Bevacizumab

Somatostatin

Octreotide

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Antineoplastic Agents, Hormonal

bevacizumab + octreotide + metronomic capecitabine

long acting octreotide acetate at a dose of 20 or 30 mg administered intramuscularly every 4 weeks; Bevacizumab at a dose of 5 mg/kg every 2 weeks; orally capecitabine administered at a dose of 2000 mg/daily

bevacizumab + octreotide LAR + capecitabine

Maria P Brizzi, MD, PhD

Anna Ferrero, MD

Elisabetta Nobili, MD

Guido Biasco, MD, PhD

Alfredo Berruti, MD, PhD

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.

Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors

Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors

All adverse events encountered during the clinical study will be reported. The intensity of clinical adverse events will be graded according to the NCI Common Toxicity Criteria (CTC) version 3.0 grading system.

TTF is the time from first day of treatment to the first occurrence of any adverse events with withdrew prematurely the treatment.

Overall survival (OS) will be computed as the time between the first day of treatment and the date of death or the last date the patient was known to be alive.

University of Turin, Italy

Alfredo Berruti

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors	NCT01203306	Neuroendocrine ...	bevacizumab + o...	18 Years - 80 Years	University of Turin, Italy
Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors	NCT01203306	Neuroendocrine ...	bevacizumab + o...	18 Years - 80 Years	University of Turin, Italy

Spots Global Cancer Trial Database for bevacizumab + octreotide lar + capecitabine