Chemotherapy for Liver Cancer
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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, participants should be treatment naive, meaning they haven't had certain chemotherapy treatments before, so it's best to discuss your specific medications with the trial team.
What evidence supports the effectiveness of the drug Irinotecan for treating liver cancer?
Is irinotecan generally safe for humans?
How does the drug Irinotecan differ from other treatments for liver cancer?
Research Team
Skye C. Mayo, MD, MPH
Principal Investigator
OHSU Knight Cancer Institute
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Systemic induction of mFOLFIRINOX for 4 cycles with a 25% dose reduction of oxaliplatin, irinotecan, and fluorouracil
Treatment Period 2
HAI delivery of floxuridine-dexamethasone with concurrent systemic mFOLFIRI for 2 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dexamethasone
- Floxuridine
- Irinotecan
- Oxaliplatin
Irinotecan is already approved in United States, European Union, Japan, Canada for the following indications:
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Small cell lung cancer
- Colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
OHSU Knight Cancer Institute
Lead Sponsor
Oregon Health and Science University
Collaborator