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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01203306
• Date of registration: 09/09/2010
• Primary sponsor: University of Turin, Italy
• Public title: Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors XELBEVOCT
• Scientific title: Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors
• Date of first enrolment: January 2006
• Target sample size: 42
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01203306
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy

Contacts

• Name: Maria P Brizzi, MD, PhD

• Name: Alfredo Berruti, MD, PhD
• Affiliation: Medical Oncology, Department of Clinical and Biological Sciences, University of Turin

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Neuroendocrine Carcinomas

Intervention(s)

Drug: bevacizumab + octreotide LAR + capecitabine

Primary Outcome(s)

time to progression [Time Frame: 36 months]

Secondary Outcome(s)

Overall survival (OS) [Time Frame: 48 months]

Time to Treatment Failure (TTF) [Time Frame: two years]

Toxicity [Time Frame: two years]

Secondary ID(s)

EudraCT 2006-004748-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors