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

Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial

Phase 3

Completed

Conditions: Head and Neck Neoplasms

Interventions: Drug: DOCETAXEL
Drug: CISPLATIN
Drug: 5-FLUOROURACIL

First Posted Date: 2009-10-15

Last Posted Date: 2018-03-02

Lead Sponsor: Sanofi

Target Recruit Count: 240

Registration Number: NCT00995293

Locations: 🇨🇳
Sanofi Administrative Office, Shanghai, China

Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer

Phase 2

Completed

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Adenocarcinoma of the Stomach
Recurrent Gastric Cancer
Stage IV Gastric Cancer
Stage IIIA Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIC Gastric Cancer

Interventions: Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Other: placebo
Drug: vismodegib
Other: laboratory biomarker analysis

First Posted Date: 2009-09-23

Last Posted Date: 2016-01-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 124

Registration Number: NCT00982592

Locations: 🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸
Decatur Memorial Hospital, Decatur, Illinois, United States
🇺🇸
New York Cancer Consortium, Bronx;, New York, United States

and more 27 locations

Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer

Phase 2

Completed

Conditions: Bladder Cancer

Interventions: Drug: cisplatin
Drug: 5-fluorouracil
Drug: Mitomycin
Radiation: Three-Dimensional Conformal Radiation Therapy

First Posted Date: 2009-09-22

Last Posted Date: 2024-04-29

Lead Sponsor: Radiation Therapy Oncology Group

Target Recruit Count: 37

Registration Number: NCT00981656

Locations: 🇺🇸
Barberton Citizens Hospital, Barberton, Ohio, United States
🇺🇸
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
University of Texas Medical Branch, Galveston, Texas, United States

and more 10 locations

Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer

Phase 3

Active, not recruiting

Conditions: PRETEXT IV Hepatoblastoma
PRETEXT II Hepatoblastoma
PRETEXT III Hepatoblastoma
PRETEXT I Hepatoblastoma

Interventions: Drug: Cisplatin
Procedure: Therapeutic Conventional Surgery
Drug: Doxorubicin Hydrochloride
Drug: Dexrazoxane
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Procedure: Liver Transplantation
Drug: Temsirolimus
Drug: Vincristine Sulfate

First Posted Date: 2009-09-21

Last Posted Date: 2025-01-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 236

Registration Number: NCT00980460

Locations: 🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
Michigan State University Clinical Center, East Lansing, Michigan, United States
🇺🇸
Hurley Medical Center, Flint, Michigan, United States

and more 206 locations

Study of Tumor Tissue Testing in Selecting Treatment for Patients With Metastatic or Locally Advanced Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

First Posted Date: 2009-09-14

Last Posted Date: 2013-12-19

Lead Sponsor: Medical Research Council

Target Recruit Count: 3240

Registration Number: NCT00975897

Locations: 🇬🇧
Belfast City Hospital Trust Incorporating Belvoir Park Hospital, Belfast, Northern Ireland, United Kingdom
🇬🇧
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
🇬🇧
Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom

Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 2

Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: Cetuximab
Drug: Cisplatin/Carboplatin
Drug: 5-Fluorouracil

First Posted Date: 2009-09-04

Last Posted Date: 2014-04-08

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Target Recruit Count: 33

Registration Number: NCT00971932

Locations: 🇯🇵
Research Site, Tokyo, Japan
🇯🇵
Tokai University, Kanagawa, Japan
🇯🇵
National Cancer Center East Hospital, Chiba, Japan

Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: cyclophosphamide
Drug: letrozole
Drug: docetaxel
Drug: epirubicin hydrochloride
Drug: fluorouracil

First Posted Date: 2009-08-21

Last Posted Date: 2013-08-12

Lead Sponsor: Imperial College London

Target Recruit Count: 756

Registration Number: NCT00963729

Locations: 🇬🇧
St. Mary's Hospital, London, England, United Kingdom
🇰🇷
Asan Medical Center - University of Ulsan College of Medicine, Seoul, Korea, Republic of
🇬🇧
West Middlesex University Hospital, Isleworth, England, United Kingdom

and more 2 locations

Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: gemcitabine hydrochloride
Drug: capecitabine
Drug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil

First Posted Date: 2009-08-17

Last Posted Date: 2012-01-13

Lead Sponsor: IRCCS San Raffaele

Target Recruit Count: 102

Registration Number: NCT00960284

Locations: 🇮🇹
Istituto Scientifico H. San Raffaele, Milan, Italy

Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors

Phase 2

Completed

Conditions: Recurrent Ovarian Germ Cell Tumor
Stage IV Extragonadal Seminoma
Recurrent Extragonadal Seminoma
Recurrent Malignant Extragonadal Non-Seminomatous Germ Cell Tumor
Recurrent Malignant Testicular Germ Cell Tumor
Stage III Testicular Cancer
Recurrent Malignant Extragonadal Germ Cell Tumor
Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor
Stage IV Ovarian Germ Cell Tumor

Interventions: Drug: Alvocidib Hydrochloride
Drug: Oxaliplatin
Drug: Fluorouracil
Drug: Leucovorin Calcium

First Posted Date: 2009-08-13

Last Posted Date: 2017-03-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 36

Registration Number: NCT00957905

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 7 locations

Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer

Phase 2

Terminated

Conditions: Anal Cancer

First Posted Date: 2009-08-10

Last Posted Date: 2020-02-11

Lead Sponsor: UNICANCER

Target Recruit Count: 16

Registration Number: NCT00955240

Locations: 🇫🇷
Centre Regional Rene Gauducheau, Nantes-Saint Herblain, France
🇫🇷
Centre Leon Berard, Lyon, France
🇫🇷
Centre Antoine Lacassagne, Nice, France

and more 17 locations

Drug Development Updates

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