Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019552
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Irofulven in Treating Patients With Recurrent or Persistent Ovarian Fallopian Tube or Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of MGI-114 in Patients With Recurrent or Persistent Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2002-01
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 recurrent or persistent ovarian fallopian tube or peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian fallopian tube or peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the clinical activity of irofulven in patients with recurrent or persistent ovarian epithelial cancer II Characterize the pharmacokinetic profile of this drug in these patients III Determine the pharmacodynamic relationship between plasma concentrations and clinical activity or toxicity of this drug in these patients
OUTLINE Patients are stratified according to the number of prior treatment regimens 1-2 vs 3 or more Patients receive irofulven IV over 5 minutes on days 1-5 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 4 weeks until death
PROJECTED ACCRUAL A maximum of 74 patients will be accrued for this study within 3 years
OUTLINE Patients are stratified according to the number of prior treatment regimens 1-2 vs 3 or more Patients receive irofulven IV over 5 minutes on days 1-5 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 4 weeks until death
PROJECTED ACCRUAL A maximum of 74 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| NCI-T98-0030 | None | None | None |
| NCI-98-C-0162 | None | None | None |
| MB-403 | None | None | None |