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

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