Conditions: Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief summary:
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: 5 FU intervention 3: Streptozotocin intervention 4: Xeloda
Intervention descriptions: intervention 1: 7.5mg/kg iv on day 1 every 3 weeks intervention 2: 400mg/m2/day iv on days 1-5 every 6 weeks intervention 3: 500mg/m2/day iv on days 1-5 every 6 weeks intervention 4: 1000mg/m2 po bid on days 1-14 every 3 weeks

Protocol document: