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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

No Placebo-Only Group

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

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

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I last received chemotherapy more than 3 weeks ago.

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I can care for myself but may need occasional help.

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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:

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

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I am not pregnant or breastfeeding.

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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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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