At a glance
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An Open Label Study to Evaluate the Effect of Avastin in Association With Chemotherapy on Progression-free Survival in Patients With Progressive Advanced/Metastatic Well-differentiated Digestive Endocrine Tumors of the Gastrointestinal Tract
In Brief
A Phase 2 clinical trial evaluating bevacizumab [Avastin], 5 FU, and 2 other interventions for Neoplasms. Completed, enrolled 83 participants across 27 sites.
Detailed 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.
Study Details
Timeline
Interventions
7.5mg/kg iv on day 1 every 3 weeks
400mg/m2/day iv on days 1-5 every 6 weeks
500mg/m2/day iv on days 1-5 every 6 weeks
1000mg/m2 po bid on days 1-14 every 3 weeks