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

A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck

Phase 3

Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Biological: Cetuximab
Drug: Cisplatin
Drug: 5-Fluorouracil

First Posted Date: 2010-08-09

Last Posted Date: 2014-09-03

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Target Recruit Count: 73

Registration Number: NCT01177956

Locations: 🇨🇳
Jilin Cancer Hospital, Changchun, China
🇨🇳
Fuijan Provincial Tumor Hospital, Fuijian, China
🇨🇳
Sun Yat-Sen Univesity Cancer Center, Guangzhou, China

and more 11 locations

Comparison Study of Sorafenib and 5-fluorouracil/Mitomycin for Metastatic Hepatocellular Carcinoma

Phase 2

Terminated

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: sorafenib
Drug: 5-FU
Drug: Mitomycin

First Posted Date: 2010-07-28

Last Posted Date: 2017-04-26

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 5

Registration Number: NCT01171482

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer

Phase 3

Terminated

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Biological: cetuximab
Drug: FOLFIRI regimen
Drug: FOLFOX regimen
Drug: capecitabine
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: mitomycin C
Procedure: therapeutic conventional surgery

First Posted Date: 2010-07-22

Last Posted Date: 2024-12-27

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 340

Registration Number: NCT01167725

Locations: 🇺🇸
St. Agnes Hospital Cancer Center, Baltimore, Maryland, United States
🇺🇸
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Biomarker-Guided Fluorouracil in Treating Patients With Colorectal Cancer Receiving Combination Chemotherapy

Phase 1

Completed

Conditions: Diarrhea
Neutropenia
Colorectal Cancer

Interventions: Drug: fluorouracil
Drug: leucovorin
Drug: oxaliplatin

First Posted Date: 2010-07-16

Last Posted Date: 2015-10-09

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 76

Registration Number: NCT01164215

Locations: 🇺🇸
Cancer Care of Western North Carolina, Asheville, North Carolina, United States
🇺🇸
Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina, United States
🇺🇸
Marion L. Shepard Cancer Center, Washington, North Carolina, United States

and more 2 locations

Molecular Triaging of Newly Diagnosed Breast Cancer

Not Applicable

Withdrawn

Conditions: Breast Cancer

Interventions: Drug: Paclitaxel
Drug: Fluorouracil
Drug: Doxorubicin
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Bevacizumab

First Posted Date: 2010-07-09

Last Posted Date: 2012-07-31

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT01159236

Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Paclitaxel
Drug: Carboplatin
Drug: Docetaxel
Drug: Cetuximab
Drug: Cisplatin
Radiation: Radiotherapy (RT)
Drug: Fluorouracil
Other: Chemotherapy

First Posted Date: 2010-07-01

Last Posted Date: 2024-12-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 128

Registration Number: NCT01154920

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

Phase 3

Conditions: Colorectal Cancer

Interventions: Drug: 5-fluorouracil
Drug: celecoxib
Other: placebo
Drug: oxaliplatin
Drug: leucovorin

First Posted Date: 2010-06-24

Last Posted Date: 2022-03-22

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 2527

Registration Number: NCT01150045

Locations: 🇺🇸
Mount Carmel Hospital East, Columbus, Ohio, United States
🇺🇸
Riverside Methodist Hospital, Columbus, Ohio, United States
🇺🇸
Helen F Graham Cancer Center, Newark, Delaware, United States

and more 836 locations

Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients Who Have Undergone Surgery for Advanced Hypopharyngeal Cancer, Oropharyngeal Cancer, Laryngeal Cancer, or Oral Cavity Cancer at High Risk of Recurrence

Phase 3

Withdrawn

Conditions: Head and Neck Cancer

First Posted Date: 2010-06-11

Last Posted Date: 2012-01-16

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Registration Number: NCT01142414

Epirubicin Hydrochloride, Cisplatin, and Fluorouracil or Capecitabine With or Without Lapatinib Ditosylate as First-Line Therapy in Treating Patients With Stomach Cancer or Gastroesophageal Junction Cancer

Phase 2

Terminated

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Gastric Cancer

Interventions: Drug: capecitabine
Drug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: lapatinib ditosylate

First Posted Date: 2010-05-14

Last Posted Date: 2016-10-12

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 29

Registration Number: NCT01123473

Locations: 🇧🇪
Institut Jules Bordet, Brussels, Belgium
🇵🇹
I.P.O. Francisco Gentil - Centro De Lisboa, Lisboa, Portugal
🇧🇪
U.Z. Gasthuisberg, Leuven, Belgium

and more 1 locations

Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

Phase 3

Completed

Conditions: Pancreatic Neoplasms

Interventions: Drug: Leucovorin
Drug: OXALIPLATIN
Drug: 5-Fluorouracil

First Posted Date: 2010-05-12

Last Posted Date: 2014-10-27

Lead Sponsor: Sanofi

Target Recruit Count: 108

Registration Number: NCT01121848

Locations: 🇨🇦
Investigational Site Number 124011, Greenfield Park, Canada
🇨🇦
Investigational Site Number 124010, Hamilton, Canada
🇨🇦
Investigational Site Number 124008, Sudbury, Canada

and more 12 locations

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