Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005031
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2000-04-06
Brief Title:
Irofulven in Treating Patients With Persistent or Recurrent Refractory Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of MGI-114 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2008-03
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 persistent or recurrent refractory endometrial cancer
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients who have persistent or recurrent refractory endometrial cancer
Detailed Description:
OBJECTIVES I Assess the antitumor activity of 6-hydroxymethylacylfulvene in patients with persistent or recurrent refractory endometrial carcinoma II Determine the nature and degree of toxicity of this treatment in these patients
OUTLINE This is a multicenter study Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-4 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 19-51 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-4 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 19-51 patients 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 |
|---|---|---|---|
| GOG-129L | None | None | None |