Hepatic Arterial Infusion + Chemotherapy for Colorectal Cancer Liver Metastases

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Oxaliplatin, Cisplatin, HAI FUDR

Disqualifiers: Radiation to liver, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to find the highest dose that can be given safely to people who have had liver disease resected. This is a Phase I study. The goal of a phase I study is to find a safe dose range based on side effects. The drugs that will be given by vein are OXALIPLATIN ("Oxali") plus 5-FLUOROURACIL and LEUCOVORIN ("5FU" and "LV"). This is systemic chemotherapy, since it goes to the whole body. The drugs that will be placed in the pump are FLOXURIDINE (FUDR) and DEXAMETHASONE. (The dexamethasone is not an anti-tumor drug; it helps protect healthy liver tissue from possible side effects of the FUDR.) This is the regional chemotherapy, since it goes only to the liver. The researchers have studied these drugs and know the best doses of each when they are used in patients who have not had liver resections. We do not yet know how the drugs work with each other in patients with a liver resection. This study will tell us the best doses of each drug when they are given over the same period of time.

Who Is on the Research Team?

Nancy E. Kemeny, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Abdominal and pelvic CT scans and chest CT or x-ray within 6 weeks prior to registration (MRI of abdomen may be substituted for CT of abdomen)

I last received chemotherapy more than 3 weeks ago.

Exclusion Criteria

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

I am not pregnant or breastfeeding.

I have not had radiation to the liver, but it's okay if I had pelvic radiation over 4 weeks ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hepatic arterial infusion with floxuridine and dexamethasone, and intravenous oxaliplatin plus 5-fluorouracil and leucovorin as adjuvant treatment

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Floxuridine
• Fluorouracil
• Leucovorin
• Oxaliplatin

Trial Overview 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.

How Is the Trial Designed?

Group I: Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy Experimental Treatment 8 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.

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

Approved in United States as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer
• Skin cancer

Approved in European Union as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer

Approved in Canada as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer

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+

University of Medicine and Dentistry of New Jersey

Collaborator

Trials

122

Recruited

13,300+