drugset / Trial / NCT00417976

Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

NCT00417976 ↗

Phase 2 Completed 42 enrolled Tony Bekaii-Saab Genentech, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.

Timeline

Start
2006-12
Primary completion
2010-03
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous