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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My kidney function, measured by creatinine levels or clearance, is within the required range.
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My liver cancer cannot be removed with surgery.
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I can move around and care for myself, and am fit for surgery under general anesthesia.
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My liver cancer affects less than 70% of my liver.
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My bile duct cancer diagnosis was confirmed through tissue examination.
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My condition is deemed inoperable or has multiple tumors as assessed by a liver cancer surgeon.
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My cancer has spread only slightly outside the liver.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate (DCR) - during HAI+SYS
Incidence of abnormal liver function
Secondary outcome measures
DCR - FOLFIRINOX
DCR - entire treatment
Incidence of serious post-operative complications
+5 moreSide effects data
From 2010 Phase 2 trial • 29 Patients • NCT0044876031%
Grade 3 Fatigue
28%
Grade 3 Neutropenia
17%
Grade 3 Diarrhea
10%
Grade 3 Febrile Neutropenia
10%
Grade 4 Neutropenia
3%
Grade 3Thrombocytopenia
3%
Grade 3 Deep Venous Thrombosis
3%
Grade 3 Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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 4
~2680
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
Dexamethasone
2007
Completed Phase 4
~2590
Floxuridine
2012
Completed Phase 2
~180
Implanted Medical Device
2019
Completed Early Phase 1
~80
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,721 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,846,024 Total Patients Enrolled
Skye C Mayo, MD, MPHPrincipal Investigator - OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My kidney function, measured by creatinine levels or clearance, is within the required range.I have been treated with floxuridine, oxaliplatin, or irinotecan.My liver's blood vessel structure prevents safe placement of a treatment pump.My liver cancer cannot be removed with surgery.I have treated hepatitis and my liver functions well.I currently have an infection.You have had an allergic reaction or shown signs of intolerance to implanted devices.I have signs of high blood pressure in the liver veins.I have mild or no nerve damage.I can move around and care for myself, and am fit for surgery under general anesthesia.My liver cancer affects less than 70% of my liver.My cancer has spread to nearby lymph nodes and possibly my lungs, as approved by my doctor.I have not had cancer, other than cholangiocarcinoma, in the last 5 years, except for certain low-risk types.I have not received any systemic chemotherapy for my condition.I've had several abdominal surgeries that may affect the placement of an HAI pump.I agree to use effective birth control or abstain from sex during the study.I am willing and able to attend all follow-up visits after my chemotherapy.My cancer has spread extensively outside the liver or within the abdomen.I am allergic to iodine contrast and cannot take steroids like dexamethasone.I have been diagnosed with sclerosing cholangitis.I have been diagnosed with hepatic encephalopathy.My bile duct cancer diagnosis was confirmed through tissue examination.Your body size is too small to fit the pump.My condition is deemed inoperable or has multiple tumors as assessed by a liver cancer surgeon.I have had treatment directly into my liver's blood vessels.I do not have cancer spread outside the liver found during surgery.My cancer has spread only slightly outside the liver.
Research Study Groups:
This trial has the following groups:- Group 1: mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Floxuridine been tested in any prior experiments?
"At present, 1083 trials for Floxuridine are underway with 303 of those being Phase 3 studies. These experiments mainly centre around Guangzhou in the province of Guangdong yet research is taking place at 38344 different locations worldwide."
Answered by AI
How many participants are enrolled in the trial?
"Correct. The details found on clinicaltrials.gov show that recruitment for this medical trial, which was originally posted in April 2021, is ongoing and searching for 30 participants at a single site."
Answered by AI
To what conditions is Floxuridine typically prescribed?
"Floxuridine can be employed to treat ocular conditions such as neoplasm metastasis, ophthalmia, sympathetic nerve affection and branch retinal vein occlusion."
Answered by AI
Has Floxuridine been granted authorization by the FDA?
"Due to the Phase 2 clinical trial status of Floxuridine, our team at Power has given its safety a score of 2. This implies that some evidence exists for its security yet none is present to back up claims about efficacy."
Answered by AI
Are there any openings for participation in this experiment?
"According to clinicaltrials.gov, this research study is currently in search of participants. It initially was published on April 28th 2021 and the most recent changes were made October 11th 2022."
Answered by AI
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