Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003786
Status:
WITHDRAWN
Last Update Posted:
2014-03-07
First Post:
1999-11-01
Brief Title:
Irofulven in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Trial of MGI-114 NSC 683863 Administered as a 5-Minute Infusion Daily for Five Days Every 4 Weeks in Patients With Previously Untreated Advanced Colorectal Cancer
Status:
WITHDRAWN
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
NO participants
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 with metastatic or recurrent colorectal cancer
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients with metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate of patients with metastatic or locally recurrent adenocarcinoma of the colon or rectum treated with 6-hydroxymethylacylfulvene MGI-114 II Determine the toxicity of this treatment regimen in this patient population III Study pharmacokinetics of MGI-114 in these patients IV Determine the relationship between pharmacokinetics of MGI-114 and clinical outcomes including toxicity and response to therapy in these patients
OUTLINE This is an open label multicenter study Patients receive 6-hyroxymethylacylfulvene MGI-114 IV over 5 minutes daily for 5 days Courses are repeated every 4 weeks Treatment continues for a minimum of 2 courses in the absence of unacceptable toxic effects or disease progression Patients are followed until death
PROJECTED ACCRUAL A total of 14-35 patients will be accrued for this study within 6-12 months
OUTLINE This is an open label multicenter study Patients receive 6-hyroxymethylacylfulvene MGI-114 IV over 5 minutes daily for 5 days Courses are repeated every 4 weeks Treatment continues for a minimum of 2 courses in the absence of unacceptable toxic effects or disease progression Patients are followed until death
PROJECTED ACCRUAL A total of 14-35 patients will be accrued for this study within 6-12 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 |
|---|---|---|---|
| NCI-T98-0008 | None | None | None |
| UCCRC-9635 | None | None | None |