← Back to Search

Anti-metabolites

Hepatic Arterial Infusion + Chemotherapy for Colorectal Cancer Liver Metastases

Phase 1

Waitlist Available

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease confirmed at MSKCC

Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study

Must not have

Active infection, ascites, hepatic encephalopathy

Female patients who are pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new cancer treatment for people who have had part of their liver removed. It's a combination of two drugs given through an IV, plus a third drug given through a pump that goes directly to the liver. The goal is to find the best dose of each drug to give, based on how well the patient tolerates the treatment.

Who is the study for?

This trial is for individuals with colorectal cancer that has spread to the liver, but not elsewhere. They must have had surgery to remove liver disease and should have acceptable blood counts and organ function. Prior chemotherapy is okay if it was over three weeks ago, but no prior radiation to the liver or certain chemotherapies like oxaliplatin.

What is being tested?

The study aims to find safe doses of systemic chemotherapy (OXALIPLATIN plus 5-FLUOROURACIL and LEUCOVORIN) given by vein, and regional chemotherapy (FLOXURIDINE with DEXAMETHASONE) delivered directly to the liver in patients who've had a liver resection due to metastatic colorectal cancer.

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, vomiting, low blood cell counts increasing infection risk, potential damage to healthy liver tissue which dexamethasone aims to prevent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My colorectal cancer has spread to my liver and there's no sign it has spread elsewhere.

Select...

I last received chemotherapy more than 3 weeks ago.

Select...

I can care for myself but may need occasional help.

Select...

My liver cancer can potentially be fully removed by surgery, and it hasn't spread elsewhere.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have an active infection, fluid in my abdomen, or brain issues due to liver disease.

Select...

I am not pregnant or breastfeeding.

Select...

I have previously been treated with oxaliplatin, cisplatin, or HAI FUDR.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adjuvant Hepatic Arterial Infusion & Combination ChemotherapyExperimental Treatment8 Interventions

This is a Phase I study with the primary objective of defining the maximum tolerated dose of hepatic arterial floxuridine (FUDR) and dexamethasone (Dex) given via an implanted pump in combination with intravenous oxaliplatin plus systemic fluorouracil (5FU)/leucovorin (LV) in the adjuvant setting after resection of hepatic metastases from colorectal cancer. A total of eleven dose levels will be considered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

adjuvant therapy

2004

Completed Phase 3

~3660

FOLFOX regimen

2009

Completed Phase 3

~2440

dexamethasone

1995

Completed Phase 3

~9520

conventional surgery

1994

Completed Phase 3

~13900

leucovorin calcium

1999

Completed Phase 3

~8620

oxaliplatin

2002

Completed Phase 3

~6370

floxuridine

2003

Completed Phase 3

~400

fluorouracil

1994

Completed Phase 3

~8440

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,962 Total Patients Enrolled

University of Medicine and Dentistry of New JerseyOTHER

121 Previous Clinical Trials

13,248 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,956 Previous Clinical Trials

595,518 Total Patients Enrolled

Media Library

Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00059930 — Phase 1

Colorectal Cancer Research Study Groups: Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

Colorectal Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT00059930 — Phase 1

Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00059930 — Phase 1

~1 spots leftby Jun 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.