← Back to Search

Topoisomerase I inhibitors

Chemotherapy for Liver Cancer

Phase 2

Waitlist Available

Led By Skye C Mayo, MD, MPH

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 40 ml/min (> 0.675 ml/sec) using Cockcroft-Gault equation

Surgically unresectable liver-dominant ICC, or multifocal ICC considered surgically unresectable or resection is contraindicated

Must not have

Current biliary obstruction requiring placement of endoscopic or transhepatic stents for biliary decompression

Prior treatment with floxuridine, oxaliplatin, or irinotecan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if systemic induction of mFOLFIRINOX, followed by hepatic arterial infusion floxuridine-dexamethasone administered concurrently with systemic mFOLFIRI can effectively and safely treat patients with liver-dominant ICC that cannot be removed by surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the drug infusion site, changes in blood counts leading to increased infection risk or bleeding, fatigue, nerve damage (neuropathy), digestive issues like nausea or diarrhea, and potential liver complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My liver cancer cannot be removed with surgery.

Select...

I can move around and care for myself, and am fit for surgery under general anesthesia.

Select...

My liver cancer affects less than 70% of my liver.

Select...

My bile duct cancer diagnosis was confirmed through tissue examination.

Select...

My condition is deemed inoperable or has multiple tumors as assessed by a liver cancer surgeon.

Select...

My cancer has spread only slightly outside the liver.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

My liver's blood vessel structure prevents safe placement of a treatment pump.

Select...

I currently have an infection.

Select...

I have signs of high blood pressure in the liver veins.

Select...

I have mild or no nerve damage.

Select...

I've had several abdominal surgeries that may affect the placement of an HAI pump.

Select...

I am allergic to iodine contrast and cannot take steroids like dexamethasone.

Select...

I have been diagnosed with sclerosing cholangitis.

Select...

I have been diagnosed with hepatic encephalopathy.

Select...

I have had treatment directly into my liver's blood vessels.

Select...

I do not have cancer spread outside the liver found during surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease control rate (DCR) - during HAI+SYS

Incidence of abnormal liver function

Secondary study objectives

DCR - FOLFIRINOX

DCR - entire treatment

Incidence of serious post-operative complications

+4 more

Side effects data

From 2010 Phase 2 trial • 29 Patients • NCT00448760

31%

Grade 3 Fatigue

28%

Grade 3 Neutropenia

17%

Grade 3 Diarrhea

10%

Grade 4 Neutropenia

10%

Grade 3 Febrile Neutropenia

Grade 3Thrombocytopenia

Grade 3 Deep Venous Thrombosis

Grade 3 Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: mFOLFIRINOX, Floxuridine-DEX, mFOLFIRIExperimental Treatment7 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan

2017

Completed Phase 3

~2590

Leucovorin

2005

Completed Phase 4

~6010