NCT01206296

Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma

A Phase 2 Study of Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2010-09-21
• Last updated: 2021-03-09
• Results posted: 2021-02-10

Locations

1 site across 1 country: United States