drugset / Trial / NCT00609765

Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

NCT00609765

NaSingle-groupOpen-labelTreatment

Summary

Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and streptozocin administered in 28-day cycles. Treatment will continue until progression of disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In order to reduce the risk of cardiac toxicity, doxorubicin will be administered for a maximum of 8 cycles. If disease has not progressed after 12 cycles of treatment, avastin monotherapy will continue until disease progression or withdrawal due to toxicity.

Timeline

Start
2007-08
Primary completion
2008-03
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Doxorubicin Other / unclassified 40 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject streptozocin Small molecule 400 mg/m2 Intravenous
Background Dexamethasone Small molecule 20 mg Intravenous
Background Ondansetron Other / unclassified 16 mg Intravenous