Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors
NCT ID: NCT01203306
Last Updated: 2010-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
42 participants
INTERVENTIONAL
2006-01-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Drugs: bevacizumab + octreotide LAR + capecitabine
bevacizumab + octreotide + metronomic capecitabine
bevacizumab + octreotide LAR + capecitabine
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
Interventions
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bevacizumab + octreotide LAR + capecitabine
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Dipartimento di Scienze Cliniche e Biologiche - Università di Torino
Principal Investigators
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Alfredo Berruti, MD, PhD
Role: STUDY_DIRECTOR
Medical Oncology, Department of Clinical and Biological Sciences, University of Turin
Locations
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Elisabetta Nobili
Bologna, Bologna, Italy
Lucia Tozzi
San Giovanni Rotondo, Foggia, Italy
Nicola Fazio
Milan, Milan, Italy
Anna Ferrero
Orbassano, Turin, Italy
Enrica Milanesi
Turin, Turin, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Brizzi MP, Berruti A, Ferrero A, Milanesi E, Volante M, Castiglione F, Birocco N, Bombaci S, Perroni D, Ferretti B, Alabiso O, Ciuffreda L, Bertetto O, Papotti M, Dogliotti L. Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte oncology network. BMC Cancer. 2009 Nov 3;9:388. doi: 10.1186/1471-2407-9-388.
Berruti A, Fazio N, Ferrero A, Brizzi MP, Volante M, Nobili E, Tozzi L, Bodei L, Torta M, D'Avolio A, Priola AM, Birocco N, Amoroso V, Biasco G, Papotti M, Dogliotti L. Bevacizumab plus octreotide and metronomic capecitabine in patients with metastatic well-to-moderately differentiated neuroendocrine tumors: the XELBEVOCT study. BMC Cancer. 2014 Mar 14;14:184. doi: 10.1186/1471-2407-14-184.
Other Identifiers
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EudraCT 2006-004748-22
Identifier Type: -
Identifier Source: org_study_id