Floxuridine

Overview

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
HAI-Floxuridine, or SIRT, Combined with Gemox for Patients with Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)	2024/03/15	NCT06313203	Phase 2	Active, not recruiting	Oslo University Hospital
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	2023/05/17	NCT05863195	Phase 3	Recruiting	ECOG-ACRIN Cancer Research Group
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma	2022/03/18	NCT05286814	Phase 2	Recruiting	National Cancer Institute (NCI)
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.	2021/05/24	NCT04898504	Phase 2	Active, not recruiting	Oslo University Hospital
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery	2021/05/18	NCT04891289	Phase 2	Recruiting	Memorial Sloan Kettering Cancer Center
A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma	2020/12/16	NCT04668976	Phase 2	Recruiting	Benaroya Research Institute
Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)	2020/09/17	NCT04552093	Phase 2	UNKNOWN	The Netherlands Cancer Institute
mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma	2020/02/05	NCT04251715	Phase 2	Active, not recruiting	OHSU Knight Cancer Institute
Hepatic Artery Infusion Pump for NPC Liver Metastases	2019/03/15	NCT03876574	Phase 1	Completed	Xiangya Hospital of Central South University
Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases	2019/02/27	NCT03856658	Phase 2	Active, not recruiting	Spectrum Health Hospitals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Floxuridine	Hikma Pharmaceuticals USA Inc.	0143-9270	INTRA-ARTERIAL	100 mg in 1 mL	5/15/2023
Floxuridine	Fresenius Kabi USA, LLC	63323-145	INTRA-ARTERIAL	500 mg in 5 mL	12/31/2019
Floxuridine	Cerona Therapeutics, Inc.	81643-9270	INTRA-ARTERIAL	500 mg in 1 1	6/13/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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