Fluorouracil Cream, USP 5% is a topical preparation containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite.
Fluorouracil Cream contains 5% fluorouracil in a vanishing cream base consisting of purified water, white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol, polysorbate 60 and parabens (methyl and propyl).
Fluorouracil Cream is recommended 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. Safety and efficacy in other indications have not been established.
The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Cream is approximately 93%, based on 113 lesions in 54 patients. Eighty-eight lesions treated with the cream produced 7 failures.
Published Studies Related to Fluorouracil
Irsogladine maleate reduces the incidence of fluorouracil-based
chemotherapy-induced oral mucositis. 
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. 
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. 
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. 
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.
Clinical Trials Related to Fluorouracil
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer [Recruiting]
This phase I trial studies the side effects and best dose of trametinib when given together
with fluorouracil and radiation therapy before surgery in treating patients with stage
II-III rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
trametinib together with fluorouracil and radiation therapy before surgery may make the
tumor smaller and reduce the amount of normal tissue that needs to be removed
Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, Leucovorin, and Avastin [Completed]
- To determine the toxicity and tolerability of intra-arterial hepatic oxaliplatin every
three weeks administered in combination with systemic intravenous Fluorouracil,
Leucovorin and bevacizumab to patients with advanced solid tumors metastatic to the
- To document in a descriptive fashion the antitumor efficacy of this combination
- To evaluate the feasibility and accuracy of an alternate radiographic assessment tool
and compare with available tumor markers and RECIST guidelines.
- To estimate in a descriptive fashion the development of extrahepatic tumor recurrences.
CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery [Recruiting]
This pilot phase I trial studies the side effects and best dose of CPI-613 when given
together with fluorouracil in treating patients with colorectal cancer that has spread to
other parts of the body and cannot be removed by surgery. CPI-613 may kill tumor cells by
turning off their mitochondria. Mitochondria are used by tumor cells to produce energy and
are the building blocks needed to make more tumor cells. By shutting off these mitochondria,
CPI-613 deprives the tumor cells of energy and other supplies that they need to survive and
grow in the body. Drugs used in chemotherapy, such as fluorouracil, work in different ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Giving CPI-613 with fluorouracil may kill more
P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma. [Recruiting]
To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy,
interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with
hepatocellular carcinoma with portal vein tumor thrombus.
Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients [Completed]
Phase I Objectives
1. The primary objective of this study is to determine the maximum tolerated dose (MTD) of
Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated,
locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal
1. To determine the qualitative and quantitative toxicity and reversibility of toxicity of
Phase II Objectives
1. To assess time to cancer progression to D-FOX treatment regimen.
1. To assess response rate to D-FOX treatment regimen.
2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of
this combination treatment regimen.
3. Determine overall survival.
4. Perform an exploratory investigation into the effect of D-FOX on phenotypic
abnormalities in blood.
Reports of Suspected Fluorouracil Side Effects
Febrile Neutropenia (124),
Decreased Appetite (105),
Stomatitis (103), more >>
Page last updated: 2014-11-30