Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas
- Compare the disease-free interval in patients with adenocarcinoma of the pancreas
treated with surgical resection followed by adjuvant gemcitabine hydrochloride with vs
- Compare overall survival in patients treated with these regimens.
- Evaluate tumor gene expression profiles and levels of tumor angiogenesis markers to
establish prognostic indicators for response in patients treated with these regimens.
OUTLINE: This is a randomized, controlled study.
All patients undergo surgical resection for the pancreatic tumor. Within 4-8 weeks after
surgery, patients are stratified according to projected 2-year survival (≤ 5% vs > 5% and ≤
33% vs > 33%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and
15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28
days for 6 courses. Patients then receive bevacizumab IV alone every 2 weeks for up to
2 years in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8,
and 15. Treatment repeats every 28 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
Primary Purpose: Treatment
Richard E. Royal, MD, FACS
National Cancer Institute (NCI)
United States: Federal Government