mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT04251715
Phase
PHASE2
Status
Terminated

Conditions

  • Liver and Intrahepatic Bile Duct Carcinoma
  • Stage III Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
  • Unresectable Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Given intraarterially via HAI pump
  • Floxuridine — DRUG
    Given intraarterially via HAI pump
  • Implanted Medical Device — DEVICE
    Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy
  • Irinotecan — DRUG
    Given IV
  • Leucovorin — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

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.

Key Dates

First listed
Feb 5, 2020
Start date
Apr 28, 2021
Status verified
May 2026
Primary completion
Mar 20, 2024
Completion
Mar 20, 2024

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI
    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 144 mg/m2 iv over 90 minutes * 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 150 mg/m2 iv over 30 minutes to 1 hour * Folinic acid 400mg/m2 iv over 30 minutes to 1 hour * 5-FU 1200 mg/m2 continuous infusion over 46 hours

Primary Outcome Measure

Frequency of Abnormal Liver Function [ Time Frame: Up to 6 months after starting HAI with floxuridine ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239-

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By research site
OHSU Knight Cancer Institute· Portland, OR

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