Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors
18 Years
80 Years
Both
Neuroendocrine Carcinomas
Trial Information
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.
Inclusion Criteria:
- Histologically or cytologically diagnosis of well-differentiated neuroendocrine
carcinoma
- Inoperable disease
- Age > 18
- ECOG Performance Status 0-2
- Life expectancy of at least 12 weeks
- Measurable and/or evaluable lesions according to RECIST criteria
- Radiological documentation of disease progression
- Adequate bone marrow reserve
- Adequate hepatic and renal function
- Urine dipstick of proteinuria < 2+
- Written informed consent
- Comply with the protocol procedures
Exclusion criteria:
- Serious non-healing wound or ulcer
- Evidence of bleeding diathesis or coagulopathy
- Uncontrolled hypertension
- Clinically significant cardiovascular disease for example cerebrovascular accidents
(≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart
Association (NYHA) grade II or greater congestive heart failure, serious cardiac
arrhythmia requiring medication
- Current or recent ongoing treatment with anticoagulants for therapeutic purposes
- Chronic, daily treatment with high-dose aspirin (>325 mg/day) or other medications
known to predispose to gastrointestinal ulceration
- Patients with severe renal impairment (creatinine clearance below 30 ml/min)
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study treatment start, or anticipation of the need for major surgical
procedure during the course of the study
- Pregnant or lactating women.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
time to progression
Outcome Time Frame:
36 months
Safety Issue:
Yes
Principal Investigator
Alfredo Berruti, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Medical Oncology, Department of Clinical and Biological Sciences, University of Turin
Authority:
Italy: AIFA - The Italian Medicines Agency
Study ID:
EudraCT 2006-004748-22
NCT ID:
NCT01203306
Start Date:
January 2006
Completion Date:
December 2010
Related Keywords:
- Neuroendocrine Carcinomas
- bevacizumab
- somatostatin analogue
- metronomic capecitabine
- neuroendocrine tumors
- Carcinoma
- Carcinoma, Neuroendocrine
- Neuroendocrine Tumors
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