HAIP Chemotherapy for Metastatic Colorectal Cancer

Palo Alto (17 mi)

Overseen byJonathan M Hernandez, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Background: Many people with colorectal cancer get liver metastases. Standard treatment for this is a combination of chemotherapy drugs. Directing the chemotherapy to the liver may be effective. A device that does this a pump that delivers drugs over 2 weeks at constant rate into the hepatic artery. The person s body temperature causes the drug to flow from the pump. Researchers want to see if this helps people with colorectal metastases to the liver. Objective: To study the effectiveness of a hepatic artery infusion pump at treating colorectal metastases to the liver. Eligibility: Adults at least 18 years old with colorectal metastases to the liver Design: Participants will be screened with: Medical history Physical exam Heart, blood, and urine tests Scans Participants will stay in the hospital a few days. A small plastic tube (catheter) will be inserted in an artery into the liver. The catheter will be attached to the pump. That will lie under the skin on the abdomen. It will be small and participants will be able to feel it. Participants will get treatment in 28-day cycles. Every Day 1, they will have physical exam, symptom review, and blood tests. Every 2 weeks, they will come to the clinic to get chemotherapy by a catheter or port. Every 12 weeks, they will have a scan. Tissue samples may be taken during the study. When they finish the drug, participants may have the pump removed. They will repeat the Day 1 tests. They will be called every 6 months to see how they are doing.

Eligibility Criteria

Adults over 18 with colorectal cancer that has spread to the liver, who have tried or can't tolerate certain chemotherapy regimens. They must be in good physical condition (ECOG ≤1), have proper organ and marrow function, and agree to use contraception. Excluded are those with high-risk genetic features needing other treatments, serious illnesses, active infections like Hepatitis B/C, pregnant/nursing women, other cancers within five years (except some skin/thyroid cancers), or those eligible for complete surgical removal of liver metastases.

Inclusion Criteria

My diagnosis is colorectal adenocarcinoma confirmed by lab tests.

My cancer did not respond or worsened after treatment with specific chemotherapy drugs.

I am 18 years old or older.

I am fully active or have some restrictions but can still care for myself.

I have cancer that has spread to my liver and it can be measured.

My kidney function tests are within normal range.

Exclusion Criteria

My liver cancer can be surgically removed until there's no visible disease.

I have MSI-high cancer and need treatment with checkpoint inhibitors.

I do not have any serious illnesses that my doctor thinks could make this study unsafe for me.

I am not pregnant or breastfeeding if I want to participate in this study.

I do not have an active Hepatitis B or C infection.

I have had radiation therapy to my liver.

My cancer has spread beyond my colon/rectum and liver, making liver-focused treatments unlikely to help.

Treatment Details

The trial is testing a hepatic artery infusion pump delivering Floxuridine and Dexamethasone directly into the liver combined with systemic chemotherapy drugs like cetuximab and irinotecan. Participants will undergo cycles of treatment including regular exams, blood tests every two weeks for chemo via catheter/port, scans every three months, and possible tissue sampling.

1Treatment groups

Experimental Treatment

Group I: 1/ Arm 1Experimental Treatment9 Interventions

HAIP chemotherapy + Systemic chemotherapy

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dexamethasone for: