This is a phase II study evaluating the use of intraperitoneal gemcitabine given intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer. The primary objective of this study is to evaluate the overall safety of intraperitoneal gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable pancreatic adenocarcinoma. The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected in overall survival at 2-years, to study the patterns of disease recurrence following this treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in peritoneal cytology with pancreatic cancer resection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2 Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Grade III and IV Complications
Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer
Time frame: Occurring during hospitalization or within 30 days of surgery, whichever is longer
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