Fluorouracil

Generic Name: Fluorouracil

Brand Names: Actikerall, Carac, Efudex, Fluoroplex, Tolak

Drug Type: Small Molecule

Chemical Formula: C_₄H_₃FN_₂O_₂

CAS Number: 51-21-8

Unique Ingredient Identifier: U3P01618RT

Background: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the thymidylate synthetase conversion of deoxyuridylic acid to thymidylic acid.

Indication: For the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.

Associated Conditions: Actinic Keratosis (AK), Breast Cancer, Colon Cancer, Gastric Cancer, Pancreatic Cancer, Rectal Cancer, Superficial Basal Cell Carcinoma, Verruca (Warts), Hyperkeratotic actinic keratosis

Associated Therapies: -

Clinical Trials

Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)

Phase 1

Terminated

Conditions: Neoplasms

Interventions: Biological: Robatumumab
Biological: Trastuzumab
Drug: Carboplatin
Drug: Epirubicin
Drug: Everolimus
Drug: Gemcitabine
Biological: Cetuximab
Drug: 5-FU
Drug: Erlotinib
Drug: Paclitaxel
Drug: Cisplatin
Drug: Irinotecan
Drug: Folinic Acid

First Posted Date: 2009-08-07

Last Posted Date: 2018-08-24

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 15

Registration Number: NCT00954512

Combination Chemotherapy and Bevacizumab With or Without Bevacizumab Maintenance Therapy in Treating Patients With Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Drug: FOLFIRI regimen
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium

First Posted Date: 2009-08-04

Last Posted Date: 2020-03-30

Lead Sponsor: Federation Francophone de Cancerologie Digestive

Target Recruit Count: 492

Registration Number: NCT00952029

Locations: 🇫🇷
Centre Bourgogne, Lille, France
🇫🇷
Croix Rousse, Lyon, France
🇫🇷
CHU La Timone, Marseille, France

and more 55 locations

A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: 5-Fluorouracil
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Epirubicin
Drug: Herceptin SC [trastuzumab]
Drug: Herceptin IV [trastuzumab]

First Posted Date: 2009-07-31

Last Posted Date: 2018-01-23

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 596

Registration Number: NCT00950300

Locations: 🇦🇷
Centro Medico San Roque; Oncology Dept, Tucuman, Argentina
🇭🇺
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika, Szeged, Hungary
🇲🇽
Hospital Privado San Jose; Oncologia, Obregon, Mexico

and more 103 locations

Vorinostat With XRT and 5-FU for Locally Advanced Adenocarcinoma of the Pancreas

Phase 1

Terminated

Conditions: Pancreatic Cancer
Adenocarcinoma of the Pancreas

Interventions: Radiation: Radiation therapy
Drug: 5-FU
Drug: Vorinostat

First Posted Date: 2009-07-29

Last Posted Date: 2017-05-10

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 10

Registration Number: NCT00948688

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

The Optimization of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer

Phase 2

Conditions: Cancer (Advanced Stage)

Interventions: Drug: 5-Fluorouracil

First Posted Date: 2009-07-22

Last Posted Date: 2015-06-19

Lead Sponsor: National University Hospital, Singapore

Target Recruit Count: 55

Registration Number: NCT00943137

Locations: 🇸🇬
National University Hospital, Singapore, Singapore

Vorinostat, Fluorouracil, and Leucovorin Calcium in Treating Patients With Metastatic Colorectal Cancer That Has Not Responded to Previous Treatment

Phase 2

Completed

Conditions: Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer

Interventions: Drug: fluorouracil
Drug: leucovorin calcium
Drug: vorinostat
Other: pharmacological study

First Posted Date: 2009-07-20

Last Posted Date: 2014-06-23

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 58

Registration Number: NCT00942266

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab

Phase 1

Completed

Conditions: Advanced Cancers

Interventions: Drug: HAI Oxaliplatin
Drug: 5-FU
Drug: Cetuximab
Drug: Bevacizumab
Drug: Leucovorin

First Posted Date: 2009-07-17

Last Posted Date: 2015-11-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 140

Registration Number: NCT00941499

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Prospective Randomized Trial Comparing Gastrectomy, Metastasectomy Plus Systemic Therapy Versus Systemic Therapy Alone: GYMSSA Trial

Phase 3

Completed

Conditions: Gastric Cancer

Interventions: Drug: Oxaliplatin
Drug: Irinotecan
Drug: 5-Fluorouracil
Drug: Leucovorin
Procedure: Gastrectomy and/or metastasectomy

First Posted Date: 2009-07-17

Last Posted Date: 2019-11-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 15

Registration Number: NCT00941655

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: 5-FU
Drug: bevacizumab [Avastin]
Drug: irinotecan
Drug: leucovorin
Drug: oxaliplatin

First Posted Date: 2009-07-16

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 97

Registration Number: NCT00940303

Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Phase 2

Completed

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Gastric Cancer

Interventions: Drug: fluorouracil
Drug: capecitabine
Drug: docetaxel
Drug: oxaliplatin
Radiation: radiation therapy
Procedure: therapeutic conventional surgery

First Posted Date: 2009-07-13

Last Posted Date: 2018-03-29

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 73

Registration Number: NCT00938470

Locations: 🇺🇸
Graham Hospital, Canton, Illinois, United States
🇺🇸
Illinois CancerCare - Galesburg, Galesburg, Illinois, United States
🇺🇸
Mason District Hospital, Havana, Illinois, United States

and more 182 locations

Drug Development Updates

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