Chemotherapy + Hepatic Arterial Infusion for Colorectal Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Chronic aspirin, NSAIDs

Disqualifiers: CNS tumors, Hypertension, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine and dexamethasone directly into the arteries around the tumor together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works when given together with combination chemotherapy in treating patients with colorectal cancer that has spread to the liver.

Research Team

Michael D'Angelica, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Nancy E. Kemeny, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

Exclusion Criteria

I have had a brain tumor before.

I have had a heart attack in the last 6 months.

My high blood pressure is not under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive hepatic arterial infusion therapy with floxuridine and dexamethasone, combined with systemic chemotherapy. Courses repeat every 4 weeks.

12 weeks

4 visits (in-person) every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months for 2 years, every 4 months for 3 years, and then annually.

5 years

Regular visits every 3-12 months

Treatment Details

Interventions

• Dexamethasone
• Floxuridine
• Fluorouracil
• Hepatic Arterial Infusion
• Irinotecan Hydrochloride
• Leucovorin Calcium
• Oxaliplatin

Trial Overview 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.

Participant Groups

Group I: Group 2 Experimental Treatment 5 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 1 Experimental Treatment 4 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.

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

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+