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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Start Date
January 1, 2003
Primary Completion Date
March 24, 2025
Completion Date
March 24, 2025
Last Updated
March 26, 2025
38
ACTUAL participants
FOLFOX regimen
DRUG
dexamethasone
DRUG
floxuridine
DRUG
fluorouracil
DRUG
leucovorin calcium
DRUG
oxaliplatin
DRUG
adjuvant therapy
PROCEDURE
conventional surgery
PROCEDURE
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT06696768
NCT04704661
Data Source & Attribution
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