Irofulven Compared With Fluorouracil in Treating Patients With Pancreatic Cancer

Phase 3

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Irofulven; Drug: fluorouracil

• Registration Number: NCT00033735
• Lead Sponsor: Eisai Inc.

Brief 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.

Detailed Description

OBJECTIVES: I. Compare survival of patients with gemcitabine-refractory, advanced pancreatic adenocarcinoma when treated with irofulven vs fluorouracil. II. Compare the objective tumor response rate in patients treated with these regimens. III. Compare the clinical benefit of these regimens as measured by improvement in pain and performance status in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized 2:1 to irofulven and fluorouracil treatment arms. Arm I: Patients receive irofulven IV over 30 minutes on days 1 and 15. Arm II: Patients receive fluorouracil IV continuously on days 1-28. Courses repeat every 28 days.

PROJECTED ACCRUAL: Approximately 350 patients (233 for arm I and 117 for arm II) will be accrued for this study.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2002-04-09
• Primary Completion: 2003-06
• Study First Submitted QC: 2004-01-14
• Study First Posted: 2004-01-15
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-20
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irofulven	Irofulven	-
fluorouracil	fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Survival of Irofulven vs. 5-FU	28 day cycle or until disease progression

Secondary Outcome Measures

Name	Time	Method
Objective Tumor Response of Irofulven vs. 5-FU and Clinical Benefit of Irofulven vs. 5-FU	28 day cycle or until disease progression

Trial Locations

Locations (1)

MGI Pharma, Incorporated; 🇺🇸 Bloomington, Minnesota, United States