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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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
Elisabetta Nobili
Bologna, Bologna, Italy
RECRUITINGLucia Tozzi
San Giovanni Rotondo, Foggia, Italy
COMPLETEDNicola Fazio
Milan, Milan, Italy
COMPLETEDtime to progression
Time frame: 36 months
Toxicity
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.
Time frame: two years
Time to Treatment Failure (TTF)
TTF is the time from first day of treatment to the first occurrence of any adverse events with withdrew prematurely the treatment.
Time frame: two years
Overall survival (OS)
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.
Time frame: 48 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Anna Ferrero
Orbassano, Turin, Italy
Enrica Milanesi
Turin, Turin, Italy
COMPLETED