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Fluorouracil (Fluorouracil) - Summary



It is recommended that Fluorouracil Injection, USP be given only by or under the supervision of a qualified physician who is experienced in cancer chemotherapy and who is well versed in the use of potent antimetabolites. Because of the possibility of severe toxic reactions, it is recommended that patients be hospitalized at least during the initial course of therapy.

These instructions should be thoroughly reviewed before administration of Fluorouracil Injection, USP.



Fluorouracil Injection, USP an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Each 10 mL contains 500 mg fluorouracil; pH is adjusted to approximately 9.2 with sodium hydroxide.

Fluorouracil Injection, USP is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas.
See all Fluorouracil indications & dosage >>


Published Studies Related to Fluorouracil

Irsogladine maleate reduces the incidence of fluorouracil-based chemotherapy-induced oral mucositis. [2013]
mucositis through a double-blind, placebo controlled trial... CONCLUSION: IM significantly reduced the incidence and maximum severity of oral

Recurrence rates and patient assessed outcomes of 0.5% 5-fluorouracil in combination with salicylic acid treating actinic keratoses. [2012]
practicability... CONCLUSIONS: Topical 0.5% 5-FU/SA demonstrated superior sustained clinical

A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. [2012]
maintenance therapy for metastatic colorectal cancer (MCRC)... CONCLUSIONS: Enzastaurin combined with bevacizumab-based therapy is tolerable,

Comparison of the efficacy of intralesional triamcinolone acetonide and 5-fluorouracil tattooing for the treatment of keloids. [2012]
for treatment of keloids... CONCLUSION: 5-FU tattooing was more effective than intralesional TAC for the

Therapeutic efficacy of combination therapy with intra-arterial 5-fluorouracil and systemic pegylated interferon alpha-2b for advanced hepatocellular carcinoma with portal venous invasion. [2011.11.09]
BACKGROUND: The prognosis of advanced hepatocellular carcinoma (HCC) remains poor, particularly among patients with portal vein tumor thrombosis (PVTT). This study evaluated the efficacy of combined 5-fluorouracil and pegylated interferon (PEG-IFN) alpha-2b in patients with advanced HCC... CONCLUSIONS: Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-fluorouracil and PEG-IFNalpha-2b, this new combination therapy may be useful for patients with advanced HCC. Cancer 2011;. (c) 2011 American Cancer Society. Copyright (c) 2011 American Cancer Society.

more studies >>

Clinical Trials Related to Fluorouracil

Definitive Chemoradiation With Gemcitabine and Continuous Fluorouracil (5- FU) Followed by High Dose Rate Brachytherapy or Stereotactic Body Radiation Therapy Boost in Locally Advanced Intra or Extrahepatic Cholangiocarcinoma [Recruiting]
OBJECTIVES: This study proposes to evaluate the feasibility of delivery of this treatment in terms of toxicity. If toxicity is not acceptable, the treatment is not feasible.

Primary Objectives

- To establish a preliminary assessment whether toxicity rates are acceptable in patients

with locally advanced intra or extrahepatic cholangiocarcinoma when treated with a regimen of gemcitabine every two weeks and continuous 5-FU given concurrently with external beam radiation therapy to a total dose of 45 Gy, followed by a brachytherapy or Stereotactic Body Radio Therapy (SBRT) boost.

Secondary Objectives

- To evaluate the overall survival rate, progression free survival rate, tumor response

rate, local control rate and the rate of distant metastases following gemcitabine and continuous 5-FU concurrent with radiation therapy in patients with locally advanced intra or extrahepatic cholangiocarcinoma.

- To evaluate the rate at which patients with unresectable extrahepatic

cholangiocarcinoma become resectable following gemcitabine and radiation therapy.

A Dose Escalation Study of MK1775 in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005) [Recruiting]
The study evaluates safety of MK1775 in monotherapy, and in combination with 5-FU alone or with 5-FU/CDDP in Japanese patients with solid tumor

Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI) [Recruiting]
The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when combined with standard dose 5FU/LV and FOLFIRI.

Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer [Recruiting]
The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.

Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy [Recruiting]
Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panobinostat together with fluorouracil and leucovorin calcium may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and the best dose of giving panobinostat, fluorouracil, and leucovorin calcium together in treating patients with stage IV colorectal cancer who did not respond to previous fluorouracil-based chemotherapy.

more trials >>

Reports of Suspected Fluorouracil Side Effects

Diarrhoea (254)Neutropenia (199)Nausea (173)Vomiting (144)Febrile Neutropenia (124)Thrombocytopenia (112)Leukopenia (111)Pyrexia (109)Decreased Appetite (105)Stomatitis (103)more >>

Page last updated: 2014-11-30

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