drugset / Trial / NCT00033735

Irofulven Compared With Fluorouracil in Treating Patients With Pancreatic Cancer

NCT00033735

Phase 3 Completed 158 enrolled Eisai Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether irofulven is effective in treating pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of irofulven with that of fluorouracil in treating patients who have locally advanced or metastatic pancreatic cancer that has not responded to previous treatment with gemcitabine.

Timeline

Start
2000-01
Primary completion
2003-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject fluorouracil Small molecule 250 mg/m2 Intravenous
Subject irofulven Small molecule 0.55 mg/kg Intravenous