Phase II Study of Neoadjuvant Intraperitoneal Gemcitabine and Intravenous Gemcitabine With Radiotherapy Followed by Surgery and Adjuvant Intraperitoneal Gemcitabine, Intravenous Gemcitabine, and Fluorouracil in Patients With Advanced Adenocarcinoma of the Pancreas
OBJECTIVES: I. Determine radiographic and/or pathologic response, time to disease
progression, and survival in patients with advanced adenocarcinoma of the pancreas treated
with neoadjuvant intraperitoneal gemcitabine and intravenous gemcitabine with radiotherapy
followed by surgery and adjuvant intraperitoneal gemcitabine, intravenous gemcitabine, and
II. Determine the pharmacokinetics of intraperitoneal gemcitabine in these patients.
III. Correlate patterns of mRNA expression with response to this regimen and prognosis in
PROTOCOL OUTLINE: Patients receive gemcitabine intraperitoneally (IP) every 6 hours for 4
doses on day 1. Treatment repeats in 1 week for a total of 2 courses. Beginning 1-3 weeks
after completion of IP chemotherapy, patients receive gemcitabine IV over 30-60 minutes on
day 1 or 2 of each week and radiotherapy on days 1-5 of each week for 6 weeks. Within 6
weeks after the completion of combination chemotherapy and radiotherapy, patients with
stable or responding disease undergo surgical resection. Patients with completely resected
extrapancreatic disease then receive 2 additional courses of IP gemcitabine beginning 1-3
weeks after surgery. Beginning 3 weeks after the completion of IP chemotherapy, patients
receive gemcitabine IV once weekly for a total of 3 weeks and fluorouracil IV continuously
for up to 6 months.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6
months for 3 years.
A total of 10-100 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
David L. Bartlett
National Cancer Institute (NCI)
United States: Federal Government
|Radiation Oncology Branch||Bethesda, Maryland 20892|
|Surgery Branch||Bethesda, Maryland 20892|