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

Radiation Therapy + Combination Chemotherapy as 1st-Line Therapy for Patients With Inoperable Esophageal Cancer

Phase 2

Completed

Conditions: Esophageal Cancer

Interventions: Drug: 5-FU
Drug: cisplatin
Drug: oxaliplatin
Radiation: radiation therapy
Drug: Folinic Acid

First Posted Date: 2009-03-13

Last Posted Date: 2015-12-18

Lead Sponsor: UNICANCER

Target Recruit Count: 266

Registration Number: NCT00861094

Locations: 🇫🇷
Hopital Du Bocage, Dijon, France
🇫🇷
Hopital Ambroise Pare, Boulogne-Billancourt, France
🇫🇷
Hopital Saint Andre, Bordeaux, France

and more 25 locations

Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer

Phase 2

Completed

Conditions: Gastric Cancer
Stomach Cancer

Interventions: Drug: Cetuximab
Drug: Irinotecan
Drug: Cisplatin
Procedure: Surgery
Drug: 5-FU
Radiation: Radiation

First Posted Date: 2009-03-06

Last Posted Date: 2015-12-07

Lead Sponsor: NYU Langone Health

Target Recruit Count: 30

Registration Number: NCT00857246

Locations: 🇺🇸
NYU Cancer Center, New York, New York, United States

Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Neoplasms
Neoplasm Metastasis

Interventions: Drug: aflibercept
Drug: oxaliplatin
Drug: 5-FU
Drug: Folinic Acid

First Posted Date: 2009-02-25

Last Posted Date: 2016-06-07

Lead Sponsor: Sanofi

Target Recruit Count: 268

Registration Number: NCT00851084

Locations: 🇦🇺
Sanofi-Aventis Investigational Site Number 036001, Hunter Region Mail Centre, Australia
🇩🇪
Sanofi-Aventis Investigational Site Number 276001, Hannover, Germany
🇪🇸
Sanofi-Aventis Investigational Site Number 724002, Sabadell, Spain

and more 34 locations

Prospective Study With FLOT in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Phase 2

Completed

Conditions: Gastric Cancer
Adenocarcinoma of the Esophagogastric Junction

Interventions: Drug: Docetaxel
Drug: 5-Fluorouracil
Drug: Oxaliplatin
Drug: folinic acid

First Posted Date: 2009-02-24

Last Posted Date: 2016-04-06

Lead Sponsor: Krankenhaus Nordwest

Target Recruit Count: 252

Registration Number: NCT00849615

Locations: 🇩🇪
Krankenhaus Nordwest, Frankfurt, Germany

CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial

Phase 4

Completed

Conditions: Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Skin Diseases
Carcinoma

Interventions: Drug: Placebo, vehicle control
Drug: 5-fluorouracil

First Posted Date: 2009-02-19

Last Posted Date: 2021-06-11

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 954

Registration Number: NCT00847912

Locations: 🇺🇸
VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States
🇺🇸
Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States
🇺🇸
VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States

and more 10 locations

Study of IMC-11F8 in Participants With Colorectal Cancer

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Biological: IMC-11F8 (necitumumab)
Drug: Oxaliplatin
Drug: Folinic acid (FA)
Drug: 5-FU

First Posted Date: 2009-02-03

Last Posted Date: 2016-01-29

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 44

Registration Number: NCT00835185

Locations: 🇪🇸
ImClone Investigational Site, Valencia, Spain

Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: 5-FU
Drug: Oxaliplatin
Drug: leucovorin
Procedure: mesorectal excision

First Posted Date: 2009-01-28

Last Posted Date: 2018-03-20

Lead Sponsor: Beth Israel Medical Center

Target Recruit Count: 27

Registration Number: NCT00831181

Locations: 🇺🇸
St. Luke's-Roosevelt Hospital Center - Roosevelt Division, New York, New York, United States
🇺🇸
Beth Israel Medical Center - Philipps Ambulatory Care Center, New York, New York, United States

Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Biological: bevacizumab
Drug: cyclophosphamide
Drug: docetaxel
Drug: epirubicin hydrochloride
Drug: fluorouracil

First Posted Date: 2009-01-12

Last Posted Date: 2019-10-22

Lead Sponsor: UNICANCER

Target Recruit Count: 100

Registration Number: NCT00820547

Locations: 🇫🇷
Centre Paul Papin, Angers, France
🇫🇷
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz, Besancon, France
🇫🇷
Institut Sainte Catherine, Avignon, France

and more 25 locations

Taxotere New Indication - Gastric Cancer Treatment Registration Trial

Phase 3

Completed

Conditions: Stomach Neoplasms

Interventions: Drug: 5-fluorouracil
Drug: Cisplatin
Drug: Docetaxel

First Posted Date: 2008-12-19

Last Posted Date: 2012-08-31

Lead Sponsor: Sanofi

Target Recruit Count: 243

Registration Number: NCT00811447

Locations: 🇨🇳
Sanofi-Aventis Administrative Office, Shanghai, China

A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Biological: cetuximab
Drug: 5-FU
Drug: oxaliplatin
Drug: leucovorin

First Posted Date: 2008-12-05

Last Posted Date: 2021-10-06

Lead Sponsor: NSABP Foundation Inc

Target Recruit Count: 20

Registration Number: NCT00803647

Locations: 🇺🇸
University of Iowa, Iowa City, Iowa, United States
🇺🇸
CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
🇺🇸
Edward Hospital, Naperville, Illinois, United States

and more 20 locations

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