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Corticosteroid

Chemotherapy + Hepatic Arterial Infusion for Colorectal Cancer

Phase 2

Waitlist Available

Led By Michael D'Angelica, MD

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

No clinical or radiographic evidence of extrahepatic disease

If present, the primary tumor will be resected at the time of pump placement

Must not have

History of primary CNS tumors

Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a treatment for colorectal cancer that has spread to the liver. The treatment is a combination of chemotherapy drugs and two other drugs, given directly into the arteries around the tumor.

Who is the study for?

This trial is for patients with colorectal cancer that has spread to the liver, who may have had prior chemotherapy but no hepatic arterial infusion or certain other treatments. They should not have widespread disease outside the liver, significant blood or heart conditions, active infections, or be pregnant. Adequate organ function and a good performance status are required.

What is being tested?

The study tests hepatic arterial infusion of floxuridine and dexamethasone combined with systemic chemotherapy drugs (fluorouracil, oxaliplatin, leucovorin calcium, irinotecan hydrochloride) in treating liver metastases from colorectal cancer. The goal is to see if this approach kills more tumor cells than standard treatment.

What are the potential side effects?

Potential side effects include reactions at the infusion site in the liver, general chemotherapy-related issues like nausea and fatigue, increased risk of infection due to lowered white blood cell counts, bleeding complications from low platelets count and possible damage to organs such as kidneys or liver.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has not spread outside my liver.

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My primary tumor will be removed when my pump is placed.

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My liver cancer cannot be removed by surgery, as confirmed by specialists.

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My colorectal cancer has spread to my liver.

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I can care for myself but may not be able to do active work.

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I do not have any current infections.

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My liver cancer cannot be removed by surgery.

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I do not have any bleeding disorders.

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Less than 70% of my liver is affected by cancer.

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I am fit for major liver surgery.

Exclusion Criteria

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

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I have had a brain tumor before.

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My high blood pressure is not under control.

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I have moderate to severe heart failure.

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I have moderate to severe issues with blood flow in my limbs.

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I do not have any serious wounds, ulcers, or unhealed bone fractures.

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I have an irregular heartbeat that needs medication.

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My seizures are not well controlled despite taking medication.

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I do not have a blockage in my digestive or urinary systems.

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I haven't had liver surgery, heat treatments, or radiation other than a biopsy.

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I have never been treated with floxuridine.

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I have never had treatment directly into my liver's arteries.

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I am not taking high doses of aspirin or certain pain relievers regularly.

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I have unstable chest pain.

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

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment5 Interventions

Patients receive HAI therapy as in group 1. Patients also receive irinotecan hydrochloride IV over 30 minutes and leucovorin calcium IV over 30 minutes on days 1 and 15 and fluorouracil IV continuously over 48 hours on days 1, 2, 15, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Group 1Experimental Treatment4 Interventions

Patients receive hepatic arterial infusion (HAI) therapy comprising floxuridine and dexamethasone continuously on days 1-14. Patients also receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 30 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fluorouracil

1994

Completed Phase 3

~8440

floxuridine

2003

Completed Phase 3

~400