Status:
UNKNOWN
Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors
Lead Sponsor:
University of Turin, Italy
Conditions:
Neuroendocrine Carcinomas
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Well differentiated neuroendocrine (NE) carcinomas have low proliferative activity and conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent administration of cytoto...
Detailed Description
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 capecit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01203306
Start Date
January 1 2006
End Date
December 1 2010
Last Update
September 16 2010
Active Locations (5)
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1
Elisabetta Nobili
Bologna, Bologna, Italy, 40138
2
Lucia Tozzi
San Giovanni Rotondo, Foggia, Italy, 71013
3
Nicola Fazio
Milan, Milan, Italy, 20121
4
Anna Ferrero
Orbassano, Turin, Italy, 10043