Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005070
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-04-06
Brief Title:
Irofulven in Treating Patients With Stage IVB or Recurrent Cervical Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of 6-Hydroxymethylacylfulvene HMAF MGI-114 in Patients With Advanced Cervical Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 IVB or recurrent cervical cancer
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients who have stage IVB or recurrent cervical cancer
Detailed Description:
OBJECTIVES I Evaluate the efficacy of 6-hydroxymethylacylfulvene in patients with stage IVB or recurrent cervical carcinoma II Determine the safety of this drug in this patient population
OUTLINE Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 consecutive days Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 6-19 months
OUTLINE Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 consecutive days Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 6-19 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 |
|---|---|---|---|
| CDR0000067675 | REGISTRY | None | None |
| NCI-T99-0096 | Registry Identifier | PDQ Physician Data Query | None |