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Phase III Trial Of Irofulven Vs. 5-Fluorouracil In Patients With Gemcitabine-Refractory Advanced Pancreatic Adenocarcinoma

Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ductal carcinoma of the
exocrine pancreas Locally advanced or metastatic Failed 1, but no more than 1, prior
gemcitabine-containing chemotherapy regimen (either as a single agent or in combination
with another agent) (See criteria for prior radiation using gemcitabine or fluorouracil at
diminished doses in Prior/Concurrent Therapy section) No neuroendocrine or islet cell
tumors or lymphoma of the pancreas

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
100,000/mm3 Hemoglobin at least 9 g/dL Absolute neutrophil count at least 1,500/mm3
Hepatic: Bilirubin no greater than 2.0 mg/dL AST or ALT no greater than 5.0 times upper
limit of normal (ULN) Alkaline phosphatase no greater than 5.0 times ULN Renal: Creatinine
no greater than 1.5 mg/dL Cardiovascular: No clinically significant active heart disease
Other: Fertile patients must use effective contraception No history of retinopathy or
macular degeneration No other malignancy within the past 5 years except basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix No other significant medical
and/or psychiatric condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy No concurrent
biologic therapy Chemotherapy: See Disease Characteristics At least 21 days since prior
chemotherapy and recovered No prior systemic treatment with fluorouracil,
fluorouracil-uracil, raltitrexed, or capecitabine in combination with gemcitabine Prior
fluorouracil or gemcitabine allowed as radiosensitizing agents when given 2 weeks before,
during, or 2 weeks after radiotherapy No prior cumulative mitomycin dose greater than 25
mg/m2 Endocrine therapy: Not specified Radiotherapy: At least 21 days since prior
radiotherapy and recovered Surgery: No prior surgery No concurrent surgery Other: At least
21 days since prior participation in other investigational study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival of Irofulven vs. 5-FU

Outcome Time Frame:

28 day cycle or until disease progression

Safety Issue:


Principal Investigator

MGI Medical Communications

Investigator Role:

Study Chair

Investigator Affiliation:

Eisai Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2000

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • duct cell adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms



MGI Pharma, Incorporated Bloomington, Minnesota  55437