A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma
- To determine the feasibility and safety of bevacizumab-based neoadjuvant and adjuvant
therapy in patients with resectable pancreatic adenocarcinoma.
- To determine the proportion of patients with margin-positive resections after
- To estimate overall survival of patients treated with this regimen.
- To assess the time to recurrence in patients treated with this regimen.
- To measure the change in the number of circulating endothelial precursor cells (CEC)
and VEGF expression on CEC at baseline and after the start of neoadjuvant therapy and
examine their relationship with response, time to recurrence, and survival.
- To assess the utility of dynamic contrast-enhanced spiral CT scan as surrogate
endpoints for antiangiogenic therapy.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy: Patients receive gemcitabine IV over 30 minutes on days 1 and 8;
oral capecitabine twice daily on days 1-14; and bevacizumab* IV over 30-90 minutes on
day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
NOTE: *Patients receive bevacizumab during courses 1 and 2 only.
- Surgical resection: Within 6-8 weeks after the last dose of bevacizumab, patients
undergo surgical resection of the pancreatic tumor.
- Adjuvant therapy: Beginning 6-10 weeks after surgery, patients receive up to 6
additional courses of gemcitabine, capecitabine, and bevacizumab as in neoadjuvant
Patients undergo blood sample collection at baseline and periodically during study for
biomarker correlative studies. Samples are analyzed by flow cytometry to measure levels of
circulating endothelial precursor cells and VEGF markers of angiogenesis. Patients also
undergo dynamic contrast-enhanced (DCE) spiral CT scan of the abdomen. DCE-CT imaging
studies are performed at baseline and after completion of neoadjuvant therapy (1-2 weeks
prior to surgical resection) to assess changes in tumor blood flow, blood volume, and tumor
After completion of study therapy, patients are followed periodically for at least 5 years.
Masking: Open Label, Primary Purpose: Treatment
Feasibility and safety
Renuka Iyer, MD
Roswell Park Cancer Institute
United States: Federal Government