Patients with Advanced Inoperable Well-Differentiated Neuroendocrine Tumors MedDRA version: 9.1 Level: LLT Classification code 10057270 Term: Neuroendocrine carcinoma
Conditions
Sponsors
AZIENDA OSPEDALIERA S. LUIGI GONZAGA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven diagnosis of well-differentiated neuroendocrine tumors 2. Inoperable disease not previously treated with chemotherapy (previous treatment with a somatostatin analogue is permitted) 3. Age >/= 18 4. ECOG Performance Status 0-2 (Appendix III) 5. Life expectancy of at least 12 weeks 6. Measurable and/or evaluable lesions according to RECIST criteria 7. Laboratory requirements: Neutrophils >/= 1.5 x 10 9/L and Platelets >/= 100 x 10 9/L Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Serious non-healing wound or ulcer. 2. Evidence of bleeding diathesis or coagulopathy. 3. Uncontrolled hypertension. 4. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (325 mg/day) or other medications known to predispose to gastrointestinal ulceration. 7. Treatment with any investigational drug within 30 days prior to enrolment. 8. Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications 9. Patients with severe renal impairment (creatinine clearance below 30 ml/min). In patients with moderate renal impairment at baseline (creatinine clearance 30-50 ml/min), a capecitabine dose reduction to 75% of starting dose is recommended. 10. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 11. 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. 12. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. 13. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity in terms of objective response rate (RR) of bevacizumab in combination with somatostatin analogue and capecitabine administered on a metronomic schedule.;Secondary Objective: To evaluate toxicity and the safety profile of the combination. To evaluate duration of response (DR), time to progression (TTP), time to treatment failure (TTF), and overall survival (OS).;Primary end point(s): VALUTATION OF OBJECTIVE RESPONSE RATE | — |
Countries
Italy
Outcome results
None listed