Numerous clinical trials evaluate floxuridine (FUDR) across Phase 1, Phase 2, and Phase 3 studies, primarily targeting gastrointestinal malignancies such as unresectable colorectal liver metastases, gastric cancer, cholangiocarcinoma, and pancreatic adenocarcinoma. These protocols reflect completed, active, terminated, or withdrawn recruitment statuses and are sponsored by academic medical centers—including Memorial Sloan Kettering Cancer Center and City of Hope Medical Center—as well as pharmaceutical companies like Sanofi and Jazz Pharmaceuticals. Evaluated therapeutic approaches include hepatic arterial infusion regimens and liposomal combination formulations for advanced disease.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07764497 | RECRUITING | Colorectal Adenocarcinoma Metastatic in the Liver; Liver Metastasis Colon Cancer; Liver Metastases From Colorectal Cancer; Liver Metastases of Colorectal Cancer |
Sunnybrook Health Sciences Centre |
2014-07 | PHASE2 |
| NCT06313203 | RECRUITING | Intrahepatic Cholangiocarcinoma; Chemotherapy Effect |
Oslo University Hospital |
2024-02-13 | PHASE2 |
| NCT06857773 | RECRUITING | Colorectal Neoplasms; Floxuridine; Liver Metastases; Vascular Access Device |
The Netherlands Cancer Institute |
2024-11-21 | PHASE3 |
| NCT05863195 | RECRUITING | Metastatic Colorectal Carcinoma; Metastatic Malignant Neoplasm in the Liver; Stage IV Colorectal Cancer AJCC v8; Unresectable Colorectal Carcinoma |
ECOG-ACRIN Cancer Research Group |
2023-10-19 | PHASE3 |
| NCT03856658 | ACTIVE_NOT_RECRUITING | Pancreatic Adenocarcinoma; Liver Metastases |
Corewell Health West |
2019-02-05 | PHASE2 |
| NCT05286814 | RECRUITING | Metastatic Colorectal Cancer (Mcrc); Intrahepatic Cholangiocarcinoma (Icc); Intrahepatic Bile Duct Cancer; Colorectal Neoplasms; Colorectal Cancer; Cholangiocarcinoma; Bile Duct Neoplasms; Bile Duct Cancer; Adrenocortical Carcinoma (ACC); Adrenal Cortical Carcinoma; Adrenal Gland Cancer; Adrenal Gland Neoplasms; Adrenal Cortex Neoplasms |
National Cancer Institute (NCI) |
2022-10-24 | PHASE2 |
| NCT04891289 | RECRUITING | Intrahepatic Cholangiocarcinoma |
Memorial Sloan Kettering Cancer Center |
2021-05-07 | PHASE2 |
| NCT00492999 | ACTIVE_NOT_RECRUITING | Colorectal Cancer; Metastatic Cancer |
Memorial Sloan Kettering Cancer Center |
2007-05 | PHASE2 |
| NCT03366155 | COMPLETED | Colorectal Cancer; Liver Metastases; Colorectal Adenocarcinoma; Colorectal Cancer With Hepatic Metastases; Colorectal Carcinoma |
National Cancer Institute (NCI) |
2019-06-24 | PHASE2 |
| NCT04898504 | ACTIVE_NOT_RECRUITING | Colorectal Cancer; Liver Metastases; Chemotherapy Effect |
Oslo University Hospital |
2021-08-23 | PHASE2 |
| NCT00059930 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Memorial Sloan Kettering Cancer Center |
2003-01 | PHASE1 |
| NCT01862315 | COMPLETED | Intrahepatic Cholangiocarcinoma; Peripheral Cholangiocarcinoma; Cholangiolar Carcinoma; Cholangiocellular Carcinoma |
Memorial Sloan Kettering Cancer Center |
2013-05 | PHASE2 |
| NCT00200200 | COMPLETED | Hepatic Metastases; Colon Cancer; Rectal Cancer |
Memorial Sloan Kettering Cancer Center |
2004-11-19 | PHASE2 |
| NCT05865925 | UNKNOWN | Advanced Solid Tumors |
Luye Pharma Group Ltd. |
2021-04-22 | PHASE1; PHASE2 |
| NCT02102789 | UNKNOWN | Metastatic Colorectal Cancer |
Yuhong Li |
2014-03 | PHASE3 |
| NCT03693807 | COMPLETED | Colorectal Cancer; Cholangiocarcinoma |
Memorial Sloan Kettering Cancer Center |
2018-10-18 | PHASE2 |
| NCT00410956 | COMPLETED | Liver Cancer |
Memorial Sloan Kettering Cancer Center |
2007-05-09 | PHASE2 |
| NCT04251715 | TERMINATED | 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 |
OHSU Knight Cancer Institute |
2021-04-28 | PHASE2 |
| NCT04668976 | UNKNOWN | Colorectal Cancer; Cholangiocarcinoma |
Benaroya Research Institute |
2020-11-25 | PHASE2 |
| NCT03678428 | TERMINATED | Metastatic Colorectal Cancer; Liver Metastases |
Sun Yat-sen University |
2021-12-31 | PHASE3 |
| NCT04552093 | UNKNOWN | Colorectal Neoplasms |
The Netherlands Cancer Institute |
2020-09-09 | PHASE2; PHASE3 |
| NCT04276090 | TERMINATED | Bile Duct Neoplasms; Colorectal Neoplasms |
Michael J Cavnar, MD |
2020-05-01 | |
| NCT03500874 | TERMINATED | Colorectal Cancer; Liver Metastases; HAI |
Sun Yat-sen University |
2018-05-28 | PHASE3 |
| NCT00695201 | COMPLETED | Colon Cancer; Rectal Cancer |
Memorial Sloan Kettering Cancer Center |
2000-08 | PHASE1 |
| NCT03493061 | COMPLETED | Colo-rectal Cancer; Liver Metastases |
Sun Yat-sen University |
2018-02-01 | PHASE2 |
| NCT01938729 | COMPLETED | Intrahepatic Cholangiocarcinoma; Peripheral Cholangiocarcinoma; Cholangiolar Carcinoma; Cholangiocellular Carcinoma) (ICC) |
Memorial Sloan Kettering Cancer Center |
2013-09-05 | PHASE1 |
| NCT02529774 | UNKNOWN | Resected Liver Metastases From Colorectal Cancer |
Ye Xu |
2015-09 | PHASE2; PHASE3 |
| NCT03069950 | WITHDRAWN | Colorectal Adenocarcinoma Metastatic to the Liver |
Memorial Sloan Kettering Cancer Center |
2017-02-28 | PHASE2 |
| NCT01525069 | TERMINATED | Cholangiocarcinoma; Liver Neoplasms |
Washington University School of Medicine |
2012-04-03 | PHASE1 |
| NCT00645710 | COMPLETED | Liver Metastases; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer |
City of Hope Medical Center |
2005-02-11 | PHASE1; PHASE2 |
| NCT03876574 | COMPLETED | Nasopharyngeal Carcinoma; Neoplasm Metastasis; Liver |
Xiangya Hospital of Central South University |
2011-01-01 | PHASE1 |
| NCT01749397 | COMPLETED | Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IV Ovarian Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7 |
National Cancer Institute (NCI) |
2012-12-07 | PHASE1 |
| NCT00587067 | COMPLETED | Hepatic Cancer |
Memorial Sloan Kettering Cancer Center |
2003-06 | PHASE2 |
| NCT01692704 | COMPLETED | Cholangiocellular Carcinoma |
University of Zurich |
2012-04 | PHASE1; PHASE2 |
| NCT00002842 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
City of Hope Medical Center |
1994-09 | PHASE2 |
| NCT00848783 | TERMINATED | Gastric Cancer; Gastric Adenocarcinoma; Esophageal Cancer |
NYU Langone Health |
2008-05 | PHASE2 |
| NCT00448760 | COMPLETED | Esophageal Cancer |
University of Miami |
2004-10 | PHASE2 |
| NCT00449163 | TERMINATED | Colorectal Cancer |
University of Miami |
2006-03-01 | PHASE2 |
| NCT00448682 | TERMINATED | Gastric Cancer |
University of Miami |
2005-06 | PHASE2 |
| NCT00408551 | UNKNOWN | Colorectal Cancer; Metastatic Cancer |
Goshen Health System |
2005-11 | PHASE2 |
| NCT00361842 | COMPLETED | Colorectal Neoplasms |
Jazz Pharmaceuticals |
2006-07 | PHASE2 |
| NCT00268463 | TERMINATED | Colorectal Cancer; Metastatic Cancer |
NSABP Foundation Inc |
2006-01 | PHASE3 |
| NCT00004103 | COMPLETED | Gastric Cancer |
NYU Langone Health |
1998-07 | PHASE2 |
| NCT00858338 | COMPLETED | Gastric Cancer; Stomach Cancer |
NYU Langone Health |
2002-12 | PHASE2 |
| NCT00183911 | COMPLETED | Gastric Adenocarcinoma; Gastric Cancer |
University of Southern California |
2003-11 | PHASE2 |
| NCT00005049 | COMPLETED | Colorectal Cancer; Gastric Cancer; Gastrointestinal Carcinoid Tumor; Gastrointestinal Stromal Tumor; Ovarian Cancer; Peritoneal Cavity Cancer; Small Intestine Cancer |
NYU Langone Health |
1997-05 | PHASE2 |
| NCT00008294 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Memorial Sloan Kettering Cancer Center |
2000-08 | PHASE1 |
| NCT00002716 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Alliance for Clinical Trials in Oncology |
1996-01 | PHASE3 |
| NCT00026234 | COMPLETED | Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Liver Metastases; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer |
National Cancer Institute (NCI) |
2002-02 | PHASE2 |
| NCT00063960 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Alliance for Clinical Trials in Oncology |
2003-08 | PHASE2 |
| NCT00003753 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Memorial Sloan Kettering Cancer Center |
1998-09 | PHASE2 |
| NCT00004142 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
M.D. Anderson Cancer Center |
1998-08-05 | PHASE2 |
| NCT01042691 | Completed | Unresectable Colorectal Liver Metastases |
David Bartlett|The Pittsburgh Foundation|Sanofi|University of Pittsburgh |
2003-05 | Phase 1 |
| NCT00006038 | COMPLETED | Esophageal Cancer; Gastric Cancer |
Memorial Sloan Kettering Cancer Center |
2000-02 | PHASE2 |
| NCT00002783 | COMPLETED | Gastric Cancer |
Memorial Sloan Kettering Cancer Center |
1996-05 | PHASE2 |
| NCT00695201 | Completed | Colon Cancer|Rectal Cancer |
Memorial Sloan Kettering Cancer Center|University of Medicine and Dentistry of New Jersey|Rutgers The State University of New Jersey|Sanofi |
2000-08 | Phase 1 |
| NCT00005860 | COMPLETED | Cancer |
Memorial Sloan Kettering Cancer Center |
2000-04 | PHASE1 |
| NCT00020501 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
National Institutes of Health Clinical Center (CC) |
2001-03 | PHASE3 |
| NCT00019760 | COMPLETED | Recurrent Colon Cancer; Liver Metastases; Stage IV Rectal Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer |
National Institutes of Health Clinical Center (CC) |
1999-04 | PHASE2 |
| NCT00001576 | COMPLETED | Colorectal Neoplasm; Liver Neoplasm; Neoplasm Metastasis |
National Cancer Institute (NCI) |
1997-07 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-14)
Check the
Floxuridine (FUDR)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.