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

Sponsor
University of Turin, Italy
Study ID
NCT01203306
Phase
PHASE2
Status
Unknown

Conditions

  • Neuroendocrine Carcinomas

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab + octreotide LAR + capecitabine — DRUG
    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

Study Details

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.

Key Dates

First listed
Sep 16, 2010
Start date
Jan 31, 2006
Status verified
Jul 2010
Primary completion
May 31, 2009
Completion
Dec 31, 2010

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Drugs: bevacizumab + octreotide LAR + capecitabine
    bevacizumab + octreotide + metronomic capecitabine

Primary Outcome Measure

time to progression [ Time Frame: 36 months ]

Central Contacts

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