Irofulven Compared With Fluorouracil in Treating Patients With Pancreatic Cancer

December 20, 2012 updated by: Eisai Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55437
        • MGI Pharma, Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fluorouracil
Drug: fluorouracil
5-fluorouracil will be administered via central venous catheter or PICC beginning at 250mg/m2/ day as continous infusion for a 28 day period.
Experimental: Irofulven
Drug: Irofulven
Irofulven will be given at 0.55 mg/kg per infusion on Day 1 and and Day 15 every 28 days as a 30 minute iv infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival of Irofulven vs. 5-FU
Time Frame: 28 day cycle or until disease progression
28 day cycle or until disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Tumor Response of Irofulven vs. 5-FU and Clinical Benefit of Irofulven vs. 5-FU
Time Frame: 28 day cycle or until disease progression
28 day cycle or until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Chair: MGI Medical Communications, Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

April 9, 2002

First Submitted That Met QC Criteria

January 14, 2004

First Posted (Estimate)

January 15, 2004

Study Record Updates

Last Update Posted (Estimate)

December 24, 2012

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069317
  • MGI-IROF-003
  • UARIZ-HSC-00305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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