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

Sorafenib Tosylate, Bevacizumab, Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Recurrent Rectal Carcinoma
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Recurrent Colon Carcinoma

Interventions: Biological: Bevacizumab
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Drug: Leucovorin Calcium
Drug: Sorafenib Tosylate

First Posted Date: 2011-06-28

Last Posted Date: 2017-04-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT01383343

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

Liposome-encapsulated Irinotecan Hydrochloride PEP02 or Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil as Second-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: FOLFIRI 1-Bevacizumab
Drug: fluorouracil
Drug: liposome-encapsulated irinotecan hydrochloride PEP02
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: Bevacizumab

First Posted Date: 2011-06-17

Last Posted Date: 2015-06-04

Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Target Recruit Count: 55

Registration Number: NCT01375816

Locations: 🇫🇷
Hopital Saint Antoine, Paris, France

Study of Bevacizumab + mFOLFOX6 Versus Bevacizumab + FOLFIRI With Biomarker Stratification in Participants With Previously Untreated Metastatic Colorectal Cancer (mCRC)

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: 5-Fluorouracil
Drug: Bevacizumab
Drug: Leucovorin
Drug: Irinotecan
Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2011-06-16

Last Posted Date: 2016-08-11

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 376

Registration Number: NCT01374425

CHFR Methylation Status Esophageal Cancer Study

Phase 2

Terminated

Conditions: Esophageal Cancer

Interventions: Drug: Paclitaxel
Drug: Cisplatin
Drug: Oxaliplatin
Radiation: Radiotherapy
Drug: 5-Fluorouracil
Procedure: Esophagectomy

First Posted Date: 2011-06-13

Last Posted Date: 2019-01-25

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 31

Registration Number: NCT01372202

Locations: 🇺🇸
Ronan Kelly, M.D., Baltimore, Maryland, United States

Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors

Phase 1

Completed

Conditions: Neoplasms

Interventions: Drug: Enzalutamide
Drug: Docetaxel
Drug: 5-FU
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Leucovorin
Drug: Oxaliplatin

First Posted Date: 2011-05-30

Last Posted Date: 2022-01-12

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 122

Registration Number: NCT01362374

Locations: 🇫🇷
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif, France
🇺🇸
Florida Cancer Specialists - Sarasota, Sarasota, Florida, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 8 locations

Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction

Phase 2

Completed

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Gastric Cancer

Interventions: Biological: cetuximab
Drug: cisplatin
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery

First Posted Date: 2011-05-25

Last Posted Date: 2016-05-30

Lead Sponsor: Federation Francophone de Cancerologie Digestive

Target Recruit Count: 65

Registration Number: NCT01360086

Locations: 🇫🇷
Centre Hospitalier Regional et Universitaire de Lille, Lille, France
🇫🇷
CHU - Robert Debre, Reims, France

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

Phase 3

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: 5-Fluorouracil
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Doxorubicin
Drug: Epirubicin
Drug: Paclitaxel
Drug: Placebo
Drug: Pertuzumab
Drug: Trastuzumab

First Posted Date: 2011-05-24

Last Posted Date: 2024-06-14

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 4804

Registration Number: NCT01358877

Locations: 🇺🇸
Texas Oncology - DFW, Dallas, Texas, United States
🇺🇸
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc., Columbus, Ohio, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States

and more 552 locations

PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy

Phase 2

Completed

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer

Interventions: Drug: Oxaliplatin
Drug: Leucovorin Calcium
Drug: Fluorouracil
Drug: Carboplatin
Drug: Paclitaxel
Procedure: Positron Emission Tomography
Procedure: Computed Tomography
Radiation: Radiation Therapy

First Posted Date: 2011-04-11

Last Posted Date: 2023-04-13

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 257

Registration Number: NCT01333033

Locations: 🇺🇸
Diagnostic and Treatment Center, Weston, Wisconsin, United States
🇺🇸
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
🇺🇸
Saint Joseph's Hospital, Marshfield, Wisconsin, United States

and more 65 locations

Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

Phase 3

Withdrawn

Conditions: Carcinoma, Hepatocellular

First Posted Date: 2011-04-01

Last Posted Date: 2012-06-11

Lead Sponsor: Albert Koong

Registration Number: NCT01327521

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer

Phase 1

Terminated

Conditions: Anal Cancer

Interventions: Drug: Tempol
Drug: 5-Fluorouracil
Drug: Mitomycin-C
Procedure: Radiation Therapy

First Posted Date: 2011-03-28

Last Posted Date: 2021-11-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 6

Registration Number: NCT01324141

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

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