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Trial Title:
Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors
NCT ID:
NCT01203306
Condition:
Neuroendocrine Carcinomas
Conditions: Official terms:
Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Bevacizumab
Capecitabine
Octreotide
Conditions: Keywords:
bevacizumab
somatostatin analogue
metronomic capecitabine
neuroendocrine tumors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
bevacizumab + octreotide LAR + capecitabine
Description:
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
Arm group label:
Drugs: bevacizumab + octreotide LAR + capecitabine
Other name:
Avastin
Other name:
Sandostatin LAR
Other name:
Xeloda
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Lucia Tozzi
Address:
City:
San Giovanni Rotondo
Zip:
71013
Country:
Italy
Status:
Completed
Facility:
Name:
Anna Ferrero
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Anna Ferrero, MD
Phone:
+39 011 9026
Phone ext:
526
Email:
anna.ferrero80@libero.it
Investigator:
Last name:
Maria P Brizzi, MD, PhD
Email:
Sub-Investigator
Facility:
Name:
Elisabetta Nobili
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elisabetta Nobili, MD
Phone:
051 6363
Phone ext:
680
Email:
elisabetta.nobili3@unibo.it
Investigator:
Last name:
Guido Biasco, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Nicola Fazio
Address:
City:
Milan
Zip:
20121
Country:
Italy
Status:
Completed
Facility:
Name:
Enrica Milanesi
Address:
City:
Turin
Zip:
10126
Country:
Italy
Status:
Completed
Start date:
January 2006
Completion date:
December 2010
Lead sponsor:
Agency:
University of Turin, Italy
Agency class:
Other
Source:
University of Turin, Italy
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01203306