phase II study of the combination of bevacizumab plus somatostatin analogue and metronomic capecitabine as first-line therapy in patients with advanced inoperable well-differentiated neuroendrocrine tumors - XELBEVOCT

• Conditions: Patients with Advanced Inoperable Well-Differentiated Neuroendocrine Tumors; MedDRA version: 9.1Level: LLTClassification code 10057270Term: Neuroendocrine carcinoma

• Registration Number: EUCTR2006-004748-22-IT
• Lead Sponsor: AZIENDA OSPEDALIERA S. LUIGI GONZAGA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified