64 Participants Needed

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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

MD

Michael D'Angelica, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

NE

Nancy E. Kemeny, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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
See 20 more

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.
See 14 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment5 Interventions
Group II: Group 1Experimental Treatment4 Interventions

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

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Approved in European Union as Dexamethasone for:
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Approved in United States as Dexamethasone for:
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Approved in Canada as Dexamethasone for:
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Approved in Japan as Dexamethasone for:

Find a Clinic Near You

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+
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