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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01203306
Recruitment Status : Unknown
Verified July 2010 by University of Turin, Italy.
Recruitment status was:  Recruiting
First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Information provided by:
University of Turin, Italy

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE September 16, 2010
Last Update Posted Date September 16, 2010
Study Start Date  ICMJE January 2006
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
time to progression [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
  • Toxicity [ Time Frame: two years ]
    All adverse events encountered during the clinical study will be reported. The intensity of clinical adverse events will be graded according to the NCI Common Toxicity Criteria (CTC) version 3.0 grading system.
  • Time to Treatment Failure (TTF) [ Time Frame: two years ]
    TTF is the time from first day of treatment to the first occurrence of any adverse events with withdrew prematurely the treatment.
  • Overall survival (OS) [ Time Frame: 48 months ]
    Overall survival (OS) will be computed as the time between the first day of treatment and the date of death or the last date the patient was known to be alive.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors
Official Title  ICMJE Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors
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.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Carcinomas
Intervention  ICMJE Drug: 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 Names:
  • Avastin
  • Sandostatin LAR
  • Xeloda
Study Arms  ICMJE Experimental: Drugs: bevacizumab + octreotide LAR + capecitabine
bevacizumab + octreotide + metronomic capecitabine
Intervention: Drug: bevacizumab + octreotide LAR + capecitabine
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 15, 2010)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01203306
Other Study ID Numbers  ICMJE EudraCT 2006-004748-22
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alfredo Berruti, Dipartimento di Scienze Cliniche e Biologiche - Università di Torino
Study Sponsor  ICMJE University of Turin, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alfredo Berruti, MD, PhD Medical Oncology, Department of Clinical and Biological Sciences, University of Turin
PRS Account University of Turin, Italy
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP