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

NCT01203306 | Unknown Phase 2 DMC

• 1 other identifier: EudraCT 2006-004748-22
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Neuroendocrine Carcinomas

Keywords

bevacizumab; somatostatin analogue; metronomic capecitabine; neuroendocrine tumors

Outcome Measures

Primary Outcomes (1)

• time to progression

  36 months

Secondary Outcomes (3)

• Toxicity

  two years

• Time to Treatment Failure (TTF)

  two years

• Overall survival (OS)

  48 months

Study Arms (1)

Drugs: bevacizumab + octreotide LAR + capecitabine

EXPERIMENTAL

bevacizumab + octreotide + metronomic capecitabine

Drug: bevacizumab + octreotide LAR + capecitabine

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

Also known as: Avastin, Sandostatin LAR, Xeloda

Drugs: bevacizumab + octreotide LAR + capecitabine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (5)

Elisabetta Nobili

Bologna, Bologna, 40138, Italy

RECRUITING

Lucia Tozzi

San Giovanni Rotondo, Foggia, 71013, Italy

COMPLETED

Nicola Fazio

Milan, Milan, 20121, Italy

COMPLETED

Anna Ferrero

Orbassano, Turin, 10043, Italy

RECRUITING

Enrica Milanesi

Turin, Turin, 10126, Italy

COMPLETED

Related Publications (2)

• 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.

  PMID: 19886987 BACKGROUND

• 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.

  PMID: 24628963 DERIVED

MeSH Terms

Conditions

Carcinoma, Neuroendocrine; Neuroendocrine Tumors

Interventions

Bevacizumab; Capecitabine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Alfredo Berruti, MD, PhD

  Medical Oncology, Department of Clinical and Biological Sciences, University of Turin

  STUDY DIRECTOR

Central Study Contacts

Maria P Brizzi, MD, PhD

CONTACT

+39, 011-9026; mariapia.brizzi@email.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 16, 2010
• Study Start: January 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2010
• Last Updated: September 16, 2010

Record last verified: 2010-07

Locations

IT (5)