drugset / Trial / NCT01206296

Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma

NCT01206296 ↗

Phase 2 Terminated 9 enrolled Medstar Health Research Institute
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2014-02
Completion
2014-02

Outcome

Outcome not reported

Stopped: “Study suspended”

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 Other