Pancreatic Cancer Clinical Trial
Official title:
Phase III Trial Of Irofulven Vs. 5-Fluorouracil In Patients With Gemcitabine-Refractory Advanced Pancreatic Adenocarcinoma
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.
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
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