Chemotherapy for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Skye C. Mayo, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies the efficacy and safety of systemic induction of mFOLFIRINOX, followed by hepatic arterial infusion (HAI) floxuridine-dexamethasone administered concurrently with systemic mFOLFIRI in treating patients with liver-dominant intrahepatic cholangiocarcinoma (ICC) that cannot be removed by surgery (unresectable). Drugs used in chemotherapy regimens, such as mFOLFIRINOX and mFOLFIRI (Oxaliplatin, Irinotecan, Fluorouracil, Folinic acid, Floxuridine) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Delivering chemotherapy via HAI (hepatic arterial infusion) can allow for liver-directed treatment while limiting toxic side effects typically seen with traditional chemotherapy.

Eligibility Criteria

This trial is for adults with a specific liver cancer called intrahepatic cholangiocarcinoma that can't be removed by surgery. They should not have had previous chemotherapy, must have good blood counts and organ function, and agree to use birth control. People with certain other health conditions or who've had many abdominal surgeries are excluded.

Inclusion Criteria

My kidney function, measured by creatinine levels or clearance, is within the required range.

White blood cell (WBC) >= 3000 cells/mm^3

My liver cancer cannot be removed with surgery.

Exclusion Criteria

I have a blockage in my bile duct that needed a stent.

The doctor believes that you have less than 12 weeks to live.

I have been treated with floxuridine, oxaliplatin, or irinotecan.

Participant Groups

The study tests mFOLFIRINOX followed by hepatic arterial infusion of floxuridine-dexamethasone alongside systemic mFOLFIRI. It aims to see if targeting the liver directly with these drugs helps more than standard treatment while reducing side effects.

Group I: mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI Experimental Treatment 7 Interventions

Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1 * Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours * Folinic acid 400 mg/m2 iv over 2 hours * Irinotecan 165 mg/m2 iv over 90 minutes * Fluorouracil 400 mg/m2 iv bolus after folinic acid * Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours Dosages on Cycle 2, 3, and 4 will be reduced by 25% Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days) * Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate mFOLFIRI on Day 15 * Irinotecan 180 mg/m2 iv over 30 minutes to 1 hour * Folinic acid 400mg/m2 iv over 30 minutes to 1 hour * 5-FU 1000 mg/m2 continuous infusion over 46 hours

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

🇺🇸 Approved in United States as Camptosar for:

• Colorectal cancer

🇪🇺 Approved in European Union as Irinotecan for:

• Colorectal cancer

🇯🇵 Approved in Japan as Topotecin for:

• Colorectal cancer
• Small cell lung cancer

🇨🇦 Approved in Canada as Irinotecan for:

• Colorectal cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

OHSU Knight Cancer Institute Portland, OR

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute Lead Sponsor

Oregon Health and Science University Collaborator

References