Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033735
Status:
COMPLETED
Last Update Posted:
2012-12-24
First Post:
2002-04-09
Brief Title:
Irofulven Compared With Fluorouracil in Treating Patients With Pancreatic Cancer
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
Phase III Trial Of Irofulven Vs 5-Fluorouracil In Patients With Gemcitabine-Refractory Advanced Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 21 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
OUTLINE This is a randomized open-label multicenter study Patients are randomized 21 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UARIZ-HSC-00305 | None | None | None |
| MGI-IROF-003 | None | None | None |