Drugs / Floxuridine
last change May 2026 re-read 8 days ago

Floxuridine

also known as FUDR · floxuridine (FUDR) · NSC-19893
Developed for
colorectal cancer · metastatic malignant neoplasm · metastasis from malignant tumor of colon · gastric cancer · colorectal neoplasm · esophageal cancer · cholangiolocellular carcinoma · colorectal adenocarcinoma
+26 more · colorectal carcinoma · gastric adenocarcinoma · intrahepatic cholangiocarcinoma · liver cancer · metastatic neoplasm · rectal cancer · bile duct neoplasm · cancer · carcinoid tumor · cholangiocarcinoma · colon adenocarcinoma · colon carcinoma · fallopian tube cancer · gastrointestinal stromal tumor · liver and intrahepatic bile duct neoplasm · nasopharyngeal carcinoma · ovarian cancer · pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · peritoneum cancer · primary peritoneal carcinoma · rectal carcinoma · rectum adenocarcinoma · small intestine cancer · urinary bladder cancer · urothelial carcinoma
Investigated by
National Cancer Institute (NCI) · Memorial Sloan Kettering Cancer Center · NYU Langone Health · City of Hope Medical Center · Sun Yat-sen University · University of Miami
+30 more · Washington University School of Medicine · Alliance for Clinical Trials in Oncology · NSABP Foundation Inc · Oregon Health and Science University · The Netherlands Cancer Institute · University of Medicine and Dentistry of New Jersey · Corewell Health West · Duke University · ECOG-ACRIN Cancer Research Group · Erasmus Medical Center · Food and Drug Administration (FDA) · Fudan University · Goshen Health System · Jazz Pharmaceuticals · M.D. Anderson Cancer Center · Michael J Cavnar, MD · National Institutes of Health Clinical Center (CC) · New York University · OHSU Knight Cancer Institute · Ohio State University · Queens Cancer Center of Queens Hospital · Rutgers, The State University of New Jersey · Sanofi · The Cleveland Clinic · University of Southern California · University of Texas Southwestern Medical Center · Wake Forest University · Xiangya Hospital of Central South University · Ye Xu · Yuhong Li

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) FUDR — 1970-12-18 fda.gov ↗

Trials 51

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials
Phase 1 NCT07842965 May 2027 → Feb 2028 expected colorectal carcinoma, metastatic malignant neoplasm City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 1 NCT01938729 Sep 2013 → Sep 2020 cholangiolocellular carcinoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1 NCT01749397 Dec 2012 → Oct 2017 fallopian tube cancer, primary peritoneal carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT01525069 Apr 2012 → Aug 2018 cholangiocarcinoma Washington University School of Medicine Terminated No outcome recorded
Phase 1 NCT03876574 Jan 2011 → Dec 2017 metastatic neoplasm, nasopharyngeal carcinoma Xiangya Hospital of Central South University Completed No outcome recorded
Phase 1 NCT00059930 Jan 2003 → Mar 2025 colorectal cancer, metastatic malignant neoplasm Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1 NCT00695201 Aug 2000 → Jun 2021 colon carcinoma, rectal carcinoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1 NCT00005860 Apr 2000 → ? cancer Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1 NCT00001576 Jul 1997 → Mar 2002 colorectal neoplasm, liver and intrahepatic bile duct neoplasm, metastatic neoplasm National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00645710 Feb 2005 → Feb 2018 metastasis from malignant tumor of colon, rectal cancer City of Hope Medical Center Completed No outcome recorded
Phase 229 trials · 1 met primary
Phase 2 NCT04891289 May 2021 → May 2027 expected intrahepatic cholangiocarcinoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT04251715 Apr 2021 → Mar 2024 intrahepatic cholangiocarcinoma OHSU Knight Cancer Institute Terminated No outcome recorded
Phase 2 NCT03366155 Jun 2019 → Nov 2025 colorectal adenocarcinoma, metastasis from malignant tumor of colon National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT03856658 Feb 2019 → Dec 2028 expected pancreatic adenocarcinoma Corewell Health West Active not recruiting No outcome recorded
Phase 2 NCT03493061 Feb 2018 → Dec 2020 metastasis from malignant tumor of colon Sun Yat-sen University Completed No outcome recorded
Phase 2 NCT02788201 Mar 2017 → Oct 2019 urinary bladder cancer, urothelial carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT03069950 Feb 2017 → May 2019 colorectal adenocarcinoma Memorial Sloan Kettering Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT01862315 May 2013 → Mar 2025 cholangiolocellular carcinoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2 NCT00848783 May 2008 → Aug 2011 esophageal cancer, gastric adenocarcinoma NYU Langone Health Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00410956 May 2007 → May 2024 liver cancer Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2/32 trials · 1 met primary
Phase 2/3 NCT04552093 Sep 2020 → Jun 2022 colorectal neoplasm The Netherlands Cancer Institute Unknown Met primary
Phase 2/3 NCT02529774 Sep 2015 → Sep 2020 metastasis from malignant tumor of colon Ye Xu Unknown No outcome recorded
Phase 37 trials · 1 met primary · 1 missed
Phase 3 NCT06857773 Nov 2024 → Jan 2030 expected metastasis from malignant tumor of colon The Netherlands Cancer Institute Recruiting No outcome recorded
Phase 3 NCT05863195 Apr 2024 → Jun 2029 expected colorectal carcinoma, metastatic malignant neoplasm ECOG-ACRIN Cancer Research Group Recruiting No outcome recorded
Phase 3 NCT03678428 Dec 2021 → Oct 2022 metastasis from malignant tumor of colon Sun Yat-sen University Terminated No outcome recorded
Phase 3 NCT03500874 May 2018 → Aug 2021 metastasis from malignant tumor of colon Sun Yat-sen University Terminated Missed primary
Phase 3 NCT02102789 Mar 2014 → Aug 2024 colorectal cancer Yuhong Li Unknown No outcome recorded
Phase 3 NCT00268463 Jan 2006 → Jun 2008 colorectal cancer, metastatic malignant neoplasm NSABP Foundation Inc Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT00002716 Jan 1996 → Mar 2006 colorectal cancer, metastatic malignant neoplasm Alliance for Clinical Trials in Oncology Completed Met primary
Phase 42 trials
Phase 4 NCT05634720 Jan 2024 → Nov 2025 overdue pancreatic ductal adenocarcinoma Duke University Active not recruiting No outcome recorded
Phase 4 NCT00874406 Jan 2008 → Dec 2009 colorectal cancer Fudan University Unknown No outcome recorded
Phase not applicable1 trial
— NCT04276090 May 2020 → Jan 2022 bile duct neoplasm, colorectal neoplasm Michael J Cavnar, MD Terminated No outcome recorded
Comparator or background therapy9 trials
Phase 1 NCT00008294 Background Aug 2000 → May 2006 colorectal cancer, metastatic malignant neoplasm Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1/2 NCT01692704 Background Apr 2012 → Mar 2016 cholangiocarcinoma University of Zurich Completed No outcome recorded
Phase 2 NCT06313203 Comparator Feb 2024 → Jan 2031 expected chemotherapy-induced toxicity, intrahepatic cholangiocarcinoma Oslo University Hospital Recruiting No outcome recorded
Phase 2 NCT05286814 Background Oct 2022 → Dec 2027 expected adrenal cortex carcinoma, colorectal cancer, intrahepatic cholangiocarcinoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT05139095 Background Jan 2022 → Dec 2026 expected gestational trophoblastic neoplasm Peking Union Medical College Hospital Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2026-04-15 PDS Biotechnology Corp. Results PDS Biotech Announces Publication of Positive PDS01ADC Interim Phase 2 Clinical Trial Data from Stage 1 of NCI-led Metastatic Colorectal Cancer (mCRC) Trial pdsbiotech.com ↗
78% Objective Response Rate (ORR) with PDS01ADC; Parallel trial without PDS01ADC had 35% ORR
2025-07-10 PDS Biotechnology Corp. Results PDS Biotech Announces Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results pdsbiotech.com ↗
This milestone has been achieved for the colorectal cancer cohort, and enrollment has progressed to Stage 2.

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 64 sources stand behind the page.

FieldValueCited text
Known as floxuridine “0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump” NCT02102789 ↗
56

“HAIP will be filled with mixture of Floxuridine and Dexamethasone.” NCT03366155 ↗

“FAEV \[floxuridine, actinomycin-D, etoposide, vincristine\]” NCT05139095 ↗

“Exemestane, Floxuridine, Fludarabine” NCT02788201 ↗

NCT00268463 ↗

NCT00006038 ↗

NCT00026234 ↗

NCT01862315 ↗

NCT00003753 ↗

NCT03493061 ↗

NCT00858338 ↗

Show 46 more sources

Known as floxuridine (FUDR) “floxuridine (FUDR)” NCT02102789 ↗
Known as FUDR “A Phase 1/1b Single Arm Safety Lead in Study of Leronlimab (CCR5 Blockade) With Hepatic Arterial Infusion Pump Therapy Delivering Floxuridine (FUDR) and Concurrent Systemic...” NCT07842965 ↗
25

“PHASE III STUDY OF HEPATIC ARTERY FLOXURIDINE (FUDR), LEUCOVORIN (LV), AND DEXAMETHASONE (DEX) VERSUS SYSTEMIC 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) AS TREATMENT FOR...” NCT00002716 ↗

“Prior trials have shown that surgery followed by hepatic artery infusion (HAI) of floxuridine (FUDR) alternating with systemic fluorouracil improves survival rates.” PMID 20048179 ↗ Jan 2010

“The intra-abdominal (intraperitoneal) administration of floxuridine (FUDR) is a procedure that we have studied and have determined it is a safe treatment.” NCT00183911 ↗

“Hepatic arterial infusion pump (HAIP) therapy with floxuridine (FUDR) combined with systemic therapy (SYST) could enhance conversion to resectable CRLM” PMID 42143303 ↗ May 2026

“0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.” NCT03678428 ↗

“0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.” NCT03493061 ↗

“Patients will receive the interventional treatment, which is neoadjuvant HA chemotherapy (FUDR/oxaliplatin delivered via the Hepatic Artery).” NCT05634720 ↗

“Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump” NCT04276090 ↗

“local chemotherapy comprising floxuridine (FUDR) and CF by hepatic arterial infusion (HAI) continuously on days 14-28” NCT00020501 ↗

“We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer.” NCT00874406 ↗

Show 15 more sources

Known as NSC-19893 “NSC-19893 FUDR Floxuridine” NCT00002783 ↗
Action Inhibit “It works by slowing or stopping the growth of tumor cells in your body.” NCT07842965 ↗
Route Other “hepatic arterial infusion of floxuridine (FUDR), 0.2 mg/kg/day” NCT00001576 ↗