Phase III Trial Of Irofulven Vs. 5-Fluorouracil In Patients With Gemcitabine-Refractory Advanced Pancreatic Adenocarcinoma
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival of Irofulven vs. 5-FU
28 day cycle or until disease progression
MGI Medical Communications
United States: Food and Drug Administration
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