Irofulven Compared With Fluorouracil in Treating Patients With Pancreatic Cancer

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

fluorouracil

Irofulven

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, duct cell adenocarcinoma of the pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

MGI Pharma, Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

fluorouracil

Irofulven

Arm Description

Outcomes

Primary Outcome Measures

Survival of Irofulven vs. 5-FU

Secondary Outcome Measures

Objective Tumor Response of Irofulven vs. 5-FU and Clinical Benefit of Irofulven vs. 5-FU

Full Information

NCT ID

NCT00033735

First Posted

April 9, 2002

Last Updated

December 20, 2012

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00033735

Brief Title

Irofulven Compared With Fluorouracil in Treating Patients With Pancreatic Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

January 2000 (undefined)

Primary Completion Date

June 2003 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

recurrent pancreatic cancer, duct cell adenocarcinoma of the pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

158 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fluorouracil

Arm Type

Experimental

Arm Title

Irofulven

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Description

5-fluorouracil will be administered via central venous catheter or PICC beginning at 250mg/m2/ day as continous infusion for a 28 day period.

Intervention Type

Drug

Intervention Name(s)

Irofulven

Intervention Description

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.

Primary Outcome Measure Information:

Title

Survival of Irofulven vs. 5-FU

Time Frame

28 day cycle or until disease progression

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MGI Medical Communications

Organizational Affiliation

Eisai Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

MGI Pharma, Incorporated

City

Bloomington

State/Province

Minnesota

ZIP/Postal Code

55437

Country

United States

Pancreatic Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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