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Irofulven Compared With Fluorouracil in Treating Patients With Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Eisai Medical Research Inc.
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033735
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: fluorouracil
Drug: irofulven
Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Fluorouracil Pancrelipase Ultrase 6-(Hydroxymethyl)acylfulvene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Trial Of Irofulven Vs. 5-Fluorouracil In Patients With Gemcitabine-Refractory Advanced Pancreatic Adenocarcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033735

Locations
United States, Minnesota
MGI Pharma, Incorporated
Bloomington, Minnesota, United States, 55437
Sponsors and Collaborators
Eisai Medical Research Inc.
Investigators
Study Chair: MGI Medical Communications Eisai Medical Research Inc.
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069317, MGI-IROF-003, UARIZ-HSC-00305
Study First Received: April 9, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00033735  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
duct cell adenocarcinoma of the pancreas

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Recurrence
Digestive System Diseases
Fluorouracil
Irofulven
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009