Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors (XELBEVOCT)
Recruitment status was: Recruiting
|Neuroendocrine Carcinomas||Drug: bevacizumab + octreotide LAR + capecitabine||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors|
- time to progression [ Time Frame: 36 months ]
- 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.
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Experimental: Drugs: bevacizumab + octreotide LAR + capecitabine
bevacizumab + octreotide + metronomic capecitabine
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203306
|Contact: Maria P Brizzi, MD, PhD||+39, 011-9026 ext firstname.lastname@example.org|
|San Giovanni Rotondo, Foggia, Italy, 71013|
|Orbassano, Turin, Italy, 10043|
|Contact: Anna Ferrero, MD +39 011 9026 ext 526 email@example.com|
|Sub-Investigator: Maria P Brizzi, MD, PhD|
|Bologna, Italy, 40138|
|Contact: Elisabetta Nobili, MD 051 6363 ext 680 firstname.lastname@example.org|
|Principal Investigator: Guido Biasco, MD, PhD|
|Milan, Italy, 20121|
|Turin, Italy, 10126|
|Study Director:||Alfredo Berruti, MD, PhD||Medical Oncology, Department of Clinical and Biological Sciences, University of Turin|