Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059930
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2003-05-06
Brief Title:
Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study Of Hepatic Arterial Infusion With Floxuridine And Dexamethasone In Combination With Intravenous Oxaliplatin Plus 5-Fluorouracil And Leucovorin As Adjuvant Treatment After Resection Of Hepatic Metastases From Colorectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this study is to find the highest dose that can be given safely to people who have had liver disease resected This is a Phase I study The goal of a phase I study is to find a safe dose range based on side effects The drugs that will be given by vein are OXALIPLATIN Oxali plus 5-FLUOROURACIL and LEUCOVORIN 5FU and LV This is systemic chemotherapy since it goes to the whole body The drugs that will be placed in the pump are FLOXURIDINE FUDR and DEXAMETHASONE The dexamethasone is not an anti-tumor drug it helps protect healthy liver tissue from possible side effects of the FUDR This is the regional chemotherapy since it goes only to the liver The researchers have studied these drugs and know the best doses of each when they are used in patients who have not had liver resections We do not yet know how the drugs work with each other in patients with a liver resection This study will tell us the best doses of each drug when they are given over the same period of time
Detailed Description:
None
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 |
|---|---|---|---|
| MSKCC-03005 | None | None | None |