Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003760
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
1999-11-01
Brief Title:
Irofulvene in Treating Patients With Stage III or Stage IV Pancreatic Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase II Trial of MGI 114 in Patients With Advanced Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2012-08
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
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine the survival rate at 6 months of patients with stage III or IV unresectable adenocarcinoma of the pancreas treated with 6-hydroxymethylacylfulvene MGI 114 II Determine the objective tumor response rate time to objective tumor response and duration of response in these patients if retrospective data is available time to tumor progression while on prior gemcitabine is determined III Determine the clinical benefit of MGI 114 as measured by pain improvement performance status and weight IV Determine the survival rate at 3 9 and 12 months in these patients V Gain additional information on the toxic effects and safety profile of this regimen
OUTLINE This is an open label multicenter study Patients receive 6-hydroxymethylacylfulvene MGI 114 IV over 5 minutes on days 1-5 Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed monthly for up to 1 year after therapy initiation
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 12-18 months
OUTLINE This is an open label multicenter study Patients receive 6-hydroxymethylacylfulvene MGI 114 IV over 5 minutes on days 1-5 Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed monthly for up to 1 year after therapy initiation
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| P30CA054174 | NIH | None | None |
| UTHSC-9895011082 | OTHER | None | None |
| MGI-11427P98-03 | OTHER | None | None |
| SACI-IDD-98-18 | OTHER | None | None |
| NCI-V99-1517 | OTHER | NCI | httpsreporternihgovquickSearchP30CA054174 |