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 I Line FOLFOX + Panitumumab vs 5FU + Panitumumab in RAS and BRAF WT Metastatic Colorectal Cancer Elderly Patients

Phase 2

Conditions: Elderly Metastatic Colorectal Cancer Patients

Interventions: Drug: 5-fluorouracil
Drug: l-leucovorin
Drug: oxaliplatin
Drug: panitumumab

First Posted Date: 2016-09-16

Last Posted Date: 2020-05-12

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 180

Registration Number: NCT02904031

Locations: 🇮🇹
Istituto Oncologico Veneto IRCCS, Padua, Italy

Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer

Phase 2

Suspended

Conditions: Breast Cancer

Interventions: Drug: Docetaxel
Drug: Capecitabine
Drug: Cyclophosphamide (tablet)
Drug: Fluorouracil
Drug: Epirubicin
Drug: Cyclophosphamide (injection)

First Posted Date: 2016-09-12

Last Posted Date: 2022-04-20

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Target Recruit Count: 170

Registration Number: NCT02897050

Locations: 🇨🇳
Second Xiangya Hospital of Central South University, Changsha, Hunan, China
🇨🇳
Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, China
🇨🇳
Peking University Shenzhen Hospital, Shenzhen, Guangdong, China

and more 1 locations

Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery

Early Phase 1

Completed

Conditions: Unresectable Pancreatic Carcinoma
Stage III Pancreatic Cancer
Pancreatic Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer

Interventions: Drug: Oxaliplatin
Drug: Irinotecan Hydrochloride
Drug: Leucovorin Calcium
Drug: Fluorouracil
Dietary Supplement: Ascorbic Acid

First Posted Date: 2016-09-12

Last Posted Date: 2020-01-18

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 8

Registration Number: NCT02896907

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Pancreatic Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer AJCC v6 and v7

Interventions: Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Veliparib

First Posted Date: 2016-09-07

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 123

Registration Number: NCT02890355

Locations: 🇺🇸
Katmai Oncology Group, Anchorage, Alaska, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States
🇺🇸
CHI Saint Vincent Cancer Center Hot Springs, Hot Springs, Arkansas, United States

and more 781 locations

A Study of PEP02 in Combination With 5-fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Tumors

Phase 1

Completed

Conditions: Solid Tumor

Interventions: Drug: PEP02
Drug: 5-FU
Drug: LV

First Posted Date: 2016-08-30

Last Posted Date: 2016-08-30

Lead Sponsor: PharmaEngine

Target Recruit Count: 16

Registration Number: NCT02884128

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

Phase 3

Completed

Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
Esophageal Adenocarcinoma

Interventions: Drug: Oxaliplatin
Drug: Nivolumab
Drug: Leucovorin
Drug: Ipilimumab
Drug: Capecitabine
Drug: Fluorouracil

First Posted Date: 2016-08-19

Last Posted Date: 2024-07-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 2031

Registration Number: NCT02872116

Locations: 🇯🇵
Local Institution - 0122, Minato-ku, Tokyo, Japan
🇬🇷
Local Institution - 0017, Nea Kifissia, Attikí, Greece
🇵🇱
Local Institution - 0016, Lublin, Poland

and more 176 locations

Nintedanib Plus mFOLFOX6 for Previously Untreated Metastatic Esophagogastric Adenocarcinoma (MEGAN)

Phase 2

Withdrawn

Conditions: Metastatic Disease
Esophagogastric Adenocarcinoma
No Previous Chemotherapy for Metastatic Esophagogastric Cancer

Interventions: Drug: Nintedanib
Drug: Fluorouracil
Drug: Leucovorin
Drug: Placebo
Drug: Oxaliplatin

First Posted Date: 2016-08-05

Last Posted Date: 2017-05-09

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

Registration Number: NCT02856867

To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: 5-Fluorouracil
Drug: Capecitabine
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Epirubicin

First Posted Date: 2016-07-27

Last Posted Date: 2016-07-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 182

Registration Number: NCT02846428

Study of NC-6004 in Combination With 5-FU and Cetuximab in Patients With Head and Neck Cancer

Phase 1

Terminated

Conditions: Head and Neck Neoplasms

Interventions: Drug: NC-6004
Drug: Cetuximab
Drug: 5-FU

First Posted Date: 2016-06-29

Last Posted Date: 2021-04-30

Lead Sponsor: Orient Europharma Co., Ltd.

Target Recruit Count: 4

Registration Number: NCT02817113

Locations: 🇨🇳
Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan
🇨🇳
Taipei Veterans General Hospital, Taipei, Taiwan
🇨🇳
National Taiwan University Hospital, Taipei, Taiwan

Evaluation of MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer

Phase 1

Withdrawn

Conditions: Colorectal Cancer

Interventions: Drug: MM-151
Drug: nal-IRI
Drug: Leucovorin
Drug: 5-FU

First Posted Date: 2016-05-27

Last Posted Date: 2017-01-11

Lead Sponsor: Merrimack Pharmaceuticals

Registration Number: NCT02785068

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