Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003441
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
1999-11-01
Brief Title:
Irofulven in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of MGI-114 NSC 683863 Administered Intravenously for Five Days Every 28 Days to Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2018-10
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 with metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Assess the antitumor activity of 6-hydroxymethylacylfulvene MGI-114 when given daily for 5 days every 28 days to patients with metastatic adenocarcinoma of the colon or rectum II Evaluate the qualitative and quantitative toxicities of MGI-114 given on this schedule in this patient population
OUTLINE Patients receive 6-hydroxymethylacylfulvene MGI-114 IV over 5 minutes daily for 5 consecutive days Courses are repeated every 28 days The minimum treatment period is 2 courses Treatment continues indefinitely in the absence of unacceptable toxic effects or disease progression Patients are followed at the end of every other course while on the study and then every 3 months thereafter until death
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study within 6-10 months
OUTLINE Patients receive 6-hydroxymethylacylfulvene MGI-114 IV over 5 minutes daily for 5 consecutive days Courses are repeated every 28 days The minimum treatment period is 2 courses Treatment continues indefinitely in the absence of unacceptable toxic effects or disease progression Patients are followed at the end of every other course while on the study and then every 3 months thereafter until death
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study within 6-10 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 |
|---|---|---|---|
| CDR0000066469 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchU01CA070172 |
| P30CA016672 | NIH | None | None |
| U01CA070172 | NIH | None | None |
| MDA-DM-97308 | OTHER | None | None |
| NCI-T97-0113 | None | None | None |