Floxuridine

Generic Name: Floxuridine

Drug Type: Small Molecule

Chemical Formula: C_₉H_₁₁FN_₂O_₅

CAS Number: 50-91-9

Unique Ingredient Identifier: 039LU44I5M

Background: An antineoplastic antimetabolite that is metabolized to fluorouracil when administered by rapid injection. Floxuridine is available as a sterile, nonpyrogenic, lyophilized powder for reconstitution. When administered by slow, continuous, intra-arterial infusion, it is converted to floxuridine monophosphate. It has been used to treat hepatic metastases of gastrointestinal adenocarcinomas and for palliation in malignant neoplasms of the liver and gastrointestinal tract.

Indication: For palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Also for the palliative management of liver cancer (usually administered by hepatic intra-arterial infusion).

Associated Conditions: Stage 4 gastrointestinal adenocarcinoma

Associated Therapies: Palliative Treatment

Clinical Trials

HAI-Floxuridine, or SIRT, Combined with Gemox for Patients with Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)

Phase 2

Active, not recruiting

Conditions: Intrahepatic Cholangiocarcinoma
Chemotherapy Effect

Interventions: Drug: Floxuridine
Procedure: Selective Internal Radiation Therapy (SIRT)

First Posted Date: 2024-03-15

Last Posted Date: 2024-12-04

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 39

Registration Number: NCT06313203

Locations: 🇳🇴
Oslo University Hospital, Oslo, Norway

Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial

Phase 3

Recruiting

Conditions: Metastatic Colorectal Carcinoma
Metastatic Malignant Neoplasm in the Liver
Stage IV Colorectal Cancer AJCC v8
Unresectable Colorectal Carcinoma

Interventions: Biological: Cetuximab
Biological: Bevacizumab
Procedure: Computed Tomography
Drug: Floxuridine
Drug: Fluorouracil
Procedure: Implantation
Drug: Irinotecan
Procedure: Intrahepatic Infusion Procedure
Drug: Leucovorin
Drug: Oxaliplatin
Biological: Panitumumab
Procedure: Single Photon Emission Computed Tomography

First Posted Date: 2023-05-17

Last Posted Date: 2024-11-05

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 408

Registration Number: NCT05863195

Locations: 🇺🇸
UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, Florida, United States
🇺🇸
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States
🇺🇸
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States

and more 36 locations

PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma

Phase 2

Recruiting

Conditions: Intrahepatic Cholangiocarcinoma (Icc)
Colorectal Cancer
Colorectal Neoplasms
Cholangiocarcinoma
Bile Duct Cancer
Metastatic Colorectal Cancer (Mcrc)
Intrahepatic Bile Duct Cancer
Bile Duct Neoplasms

Interventions: Drug: Floxuridine
Drug: 5-Fluorouracil
Drug: Irinotecan
Device: Intera 3000 Hepatic Artery Infusion Pump (HAIP)
Drug: Oxaliplatin
Drug: Leucovorin
Drug: PDS01ADC
Drug: Dexamethasone
Drug: Gemcitabine

First Posted Date: 2022-03-18

Last Posted Date: 2025-04-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 48

Registration Number: NCT05286814

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

HAI-Floxuridine, or Liver-Tx, Combined With 2nd Line Chemotherapy Versus 2nd Line Chemotherapy Alone for Patients With Colorectal Liver Metastases and Heavy Tumour Burden.

Phase 2

Active, not recruiting

Conditions: Liver Metastases
Colorectal Cancer
Chemotherapy Effect

Interventions: Procedure: Liver Transplantation
Drug: Floxuridine

First Posted Date: 2021-05-24

Last Posted Date: 2024-11-07

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 45

Registration Number: NCT04898504

Locations: 🇳🇴
Oslo University Hospital, Oslo, Norway

Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery

Phase 2

Recruiting

Conditions: Intrahepatic Cholangiocarcinoma

Interventions: Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Dexamethasone
Drug: Floxuridine (FUDR)
Device: Implanted Medical Device

First Posted Date: 2021-05-18

Last Posted Date: 2025-03-21

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 164

Registration Number: NCT04891289

Locations: 🇺🇸
National Heart, Lung, and Blood Institute (NIH) (Data Collection Only), Bethesda, Maryland, United States
🇺🇸
Washington University (Data Collection Only), Saint Louis, Missouri, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities, Basking Ridge, New Jersey, United States

and more 8 locations

A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma

Phase 2

Recruiting

Conditions: Colorectal Cancer
Cholangiocarcinoma

Interventions: Device: Medtronic pump and Codman catheter
Drug: Floxuridine (FUDR)
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Irinotecan (CPT-11)
Drug: Fluorouracil
Drug: Anti-EGFR (Panitumumab or Cetuximab)

First Posted Date: 2020-12-16

Last Posted Date: 2020-12-21

Lead Sponsor: Benaroya Research Institute

Target Recruit Count: 100

Registration Number: NCT04668976

Locations: 🇺🇸
Virginia mason medical Center, Seattle, Washington, United States

Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)

Phase 2

Conditions: Colorectal Neoplasms

Interventions: Drug: Floxuridine
Device: Tricumed IP2000V infusion pump

First Posted Date: 2020-09-17

Last Posted Date: 2020-09-17

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 31

Registration Number: NCT04552093

Locations: 🇳🇱
Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, Netherlands

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

Phase 2

Active, not recruiting

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