Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma
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 Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma|
- Grade III and IV Complications [ Time Frame: Occurring during hospitalization or within 30 days of surgery, whichever is longer ] [ Designated as safety issue: Yes ]Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Intraperitoneal Gemcitabine
Drug: Intraperitoneal Gemcitabine
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206296
|United States, District of Columbia|
|Washington Cancer Institute at MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Lana Bijelic, MD||Washington Hospital Center|