A Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab For Locally Advanced Pancreatic Cancer
I. Compare 1-year overall survival of patients with unresectable locally advanced pancreatic
cancer treated with capecitabine, bevacizumab, and radiotherapy followed by maintenance
therapy comprising gemcitabine and bevacizumab to a historical control.
I. Determine the frequency of serious unacceptable adverse events in patients treated with
II. Determine the response rate in patients treated with this regimen. III. Determine the
progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Chemoradiotherapy and bevacizumab: Patients receive oral capecitabine twice daily and
undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients
also receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Patients undergo
reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab.
Patients with no evidence of disease progression proceed to maintenance therapy. Patients
with a marked response may undergo surgery at the discretion of the attending surgeon and
then proceed to maintenance therapy approximately 4-8 weeks later.
Maintenance therapy: Beginning within 4-7 weeks after completion of chemoradiotherapy and
bevacizumab, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and
bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to
normal. Courses repeat every 28 days in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study within 16 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival rate
Will be estimated using the Kaplan-Meier method.
Radiation Therapy Oncology Group
United States: Food and Drug Administration
|Radiation Therapy Oncology Group||Philadelphia, Pennsylvania 19107|