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

NCT00059930 Phase 1 COMPLETED

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.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	COMPLETED
Enrolment	38
Start date	2003-01
Completion	2025-03-24

Conditions

• Colorectal Cancer
• Metastatic Cancer

Interventions

• FOLFOX regimen
• dexamethasone
• floxuridine
• fluorouracil
• leucovorin calcium
• oxaliplatin
• adjuvant therapy
• conventional surgery

Primary outcomes

• Maximum tolerated dose — 2 years
• Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and ERCC-1 with survival and recurrence as measured by normal and tumor liver tissue — 2 years

Countries

United States