Fluorouracil

Breast Cancer, Carcinoma, Basal Cell, Rectal Cancer + 6 more

Treatment

1 FDA approval

20 Active Studies for Fluorouracil

What is Fluorouracil

Fluorouracil

The Generic name of this drug

Treatment Summary

Capecitabine is a type of medication used to treat cancer. It works by interfering with the process of DNA synthesis and preventing the growth of cancer cells.

Efudex

is the brand name

image of different drug pills on a surface

Fluorouracil Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Efudex

Fluorouracil

1970

62

Approved as Treatment by the FDA

Fluorouracil, also known as Efudex, is approved by the FDA for 1 uses like Actinic keratosis .

Actinic keratosis

Used to treat hyperkeratotic actinic keratosis in combination with Salicylic acid

Effectiveness

How Fluorouracil Affects Patients

Fluorouracil is a drug that helps stop cancer cells from growing. It does this by preventing the building blocks of DNA (purine and pyrimidine) from being incorporated into the DNA during the "S" phase of the cell cycle. Fluorouracil also blocks an enzyme that changes a type of nucleotide into the deoxy derivative, and it stops the incorporation of the thymidine nucleotide into the DNA strand, which stops DNA synthesis.

How Fluorouracil works in the body

Fluorouracil works by binding to an enzyme called thymidylate synthase. This prevents the formation of a compound used in DNA and RNA synthesis, which leads to cell death. It can also interfere with protein production by taking the place of a compound normally used in RNA processing.

When to interrupt dosage

The proposed dose of Fluorouracil is contingent upon the diagnosed malady, such as Actinic Keratosis, Verruca (Warts) and non-immunocompromised. The amount of dosage can be found in the table beneath, contingent upon the method of delivery (e.g. Solution - Topical or Injection, solution).

Condition

Dosage

Administration

Breast Cancer

, 50.0 mg/mL, 0.005 mg/mg, 0.05 mg/mg, 0.04 mg/mg, 20.0 mg/mL, 5.0 %, 1.0 %, 0.5 %, 250.0 mg/mL, 0.01 mg/mg, 0.2 mg/mg, 10.0 mg/mL, 5.0 mg/mg, 125.0 mg/mL, 4.0 %, 100.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Cream - Topical, Topical, Cream, Solution - Topical, Solution, Solution - Intravenous, Liquid - Intravenous, Liquid, Kit, Injection, Injection - Intravenous

Warts

, 50.0 mg/mL, 0.005 mg/mg, 0.05 mg/mg, 0.04 mg/mg, 20.0 mg/mL, 5.0 %, 1.0 %, 0.5 %, 250.0 mg/mL, 0.01 mg/mg, 0.2 mg/mg, 10.0 mg/mL, 5.0 mg/mg, 125.0 mg/mL, 4.0 %, 100.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Cream - Topical, Topical, Cream, Solution - Topical, Solution, Solution - Intravenous, Liquid - Intravenous, Liquid, Kit, Injection, Injection - Intravenous

Actinic Keratosis

, 50.0 mg/mL, 0.005 mg/mg, 0.05 mg/mg, 0.04 mg/mg, 20.0 mg/mL, 5.0 %, 1.0 %, 0.5 %, 250.0 mg/mL, 0.01 mg/mg, 0.2 mg/mg, 10.0 mg/mL, 5.0 mg/mg, 125.0 mg/mL, 4.0 %, 100.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Cream - Topical, Topical, Cream, Solution - Topical, Solution, Solution - Intravenous, Liquid - Intravenous, Liquid, Kit, Injection, Injection - Intravenous

Actinic keratosis

, 50.0 mg/mL, 0.005 mg/mg, 0.05 mg/mg, 0.04 mg/mg, 20.0 mg/mL, 5.0 %, 1.0 %, 0.5 %, 250.0 mg/mL, 0.01 mg/mg, 0.2 mg/mg, 10.0 mg/mL, 5.0 mg/mg, 125.0 mg/mL, 4.0 %, 100.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Cream - Topical, Topical, Cream, Solution - Topical, Solution, Solution - Intravenous, Liquid - Intravenous, Liquid, Kit, Injection, Injection - Intravenous

Carcinoma, Basal Cell

, 50.0 mg/mL, 0.005 mg/mg, 0.05 mg/mg, 0.04 mg/mg, 20.0 mg/mL, 5.0 %, 1.0 %, 0.5 %, 250.0 mg/mL, 0.01 mg/mg, 0.2 mg/mg, 10.0 mg/mL, 5.0 mg/mg, 125.0 mg/mL, 4.0 %, 100.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Cream - Topical, Topical, Cream, Solution - Topical, Solution, Solution - Intravenous, Liquid - Intravenous, Liquid, Kit, Injection, Injection - Intravenous

Stomach Cancer

, 50.0 mg/mL, 0.005 mg/mg, 0.05 mg/mg, 0.04 mg/mg, 20.0 mg/mL, 5.0 %, 1.0 %, 0.5 %, 250.0 mg/mL, 0.01 mg/mg, 0.2 mg/mg, 10.0 mg/mL, 5.0 mg/mg, 125.0 mg/mL, 4.0 %, 100.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Cream - Topical, Topical, Cream, Solution - Topical, Solution, Solution - Intravenous, Liquid - Intravenous, Liquid, Kit, Injection, Injection - Intravenous

Rectal Cancer

, 50.0 mg/mL, 0.005 mg/mg, 0.05 mg/mg, 0.04 mg/mg, 20.0 mg/mL, 5.0 %, 1.0 %, 0.5 %, 250.0 mg/mL, 0.01 mg/mg, 0.2 mg/mg, 10.0 mg/mL, 5.0 mg/mg, 125.0 mg/mL, 4.0 %, 100.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Cream - Topical, Topical, Cream, Solution - Topical, Solution, Solution - Intravenous, Liquid - Intravenous, Liquid, Kit, Injection, Injection - Intravenous

Colon Cancer

, 50.0 mg/mL, 0.005 mg/mg, 0.05 mg/mg, 0.04 mg/mg, 20.0 mg/mL, 5.0 %, 1.0 %, 0.5 %, 250.0 mg/mL, 0.01 mg/mg, 0.2 mg/mg, 10.0 mg/mL, 5.0 mg/mg, 125.0 mg/mL, 4.0 %, 100.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Cream - Topical, Topical, Cream, Solution - Topical, Solution, Solution - Intravenous, Liquid - Intravenous, Liquid, Kit, Injection, Injection - Intravenous

Pancreatic Cancer

, 50.0 mg/mL, 0.005 mg/mg, 0.05 mg/mg, 0.04 mg/mg, 20.0 mg/mL, 5.0 %, 1.0 %, 0.5 %, 250.0 mg/mL, 0.01 mg/mg, 0.2 mg/mg, 10.0 mg/mL, 5.0 mg/mg, 125.0 mg/mL, 4.0 %, 100.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Cream - Topical, Topical, Cream, Solution - Topical, Solution, Solution - Intravenous, Liquid - Intravenous, Liquid, Kit, Injection, Injection - Intravenous

Warnings

Fluorouracil Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

There are 20 known major drug interactions with Fluorouracil.

Common Fluorouracil Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Fluorouracil is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Fluorouracil is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abetimus

Major

The risk or severity of adverse effects can be increased when Fluorouracil is combined with Abetimus.

Acenocoumarol

Major

The metabolism of Acenocoumarol can be decreased when combined with Fluorouracil.

Acteoside

Major

The risk or severity of adverse effects can be increased when Fluorouracil is combined with Acteoside.

Fluorouracil Toxicity & Overdose Risk

The lowest toxic dose in mice when taken orally is 230mg/kg.

image of a doctor in a lab doing drug, clinical research

Fluorouracil Novel Uses: Which Conditions Have a Clinical Trial Featuring Fluorouracil?

1138 active trials are currently assessing Fluorouracil's potential as a therapeutic agent in Stomach Cancer, Colon Cancer and Rectal Cancer.

Condition

Clinical Trials

Trial Phases

Pancreatic Cancer

183 Actively Recruiting

Phase 3, Not Applicable, Phase 2, Phase 1, Early Phase 1

Stomach Cancer

109 Actively Recruiting

Phase 2, Phase 3, Phase 1, Not Applicable, Phase 4, Early Phase 1

Rectal Cancer

40 Actively Recruiting

Phase 3, Not Applicable, Phase 1, Phase 2

Colon Cancer

42 Actively Recruiting

Not Applicable, Phase 1, Phase 2

Breast Cancer

25 Actively Recruiting

Phase 2, Not Applicable, Phase 3, Phase 1

Actinic keratosis

0 Actively Recruiting

Carcinoma, Basal Cell

0 Actively Recruiting

Warts

0 Actively Recruiting

Actinic Keratosis

10 Actively Recruiting

Not Applicable, Phase 2, Phase 1, Phase 3

Fluorouracil Reviews: What are patients saying about Fluorouracil?

5

Patient Review

2/25/2022

Fluorouracil for Roughened Red Patches of Skin due to Sun Exposure

I'm only on day 12 of the treatment, and I've already started to see results. There are still some red patches on my forehead and temples, but they're starting to itch now so I know the worst is yet to come. However, this is a small price to pay for the stupidity of not protecting myself from the sun while playing golf in my 30s.

5

Patient Review

4/16/2022

Fluorouracil for Superficial Basal Cell Carcinoma of the Skin

I've used this medication a few times now and have had great results. I simply apply it to a small area of my face, wait for the skin to start breaking down, then cover with a bandaid. After the skin heals, I can move on to another spot. It's time-consuming, but it works wonders!

5

Patient Review

3/6/2022

Fluorouracil for Superficial Basal Cell Carcinoma of the Skin

While this treatment is incredibly difficult, it's still the best option out there. I've been using it for over 30 years to combat basal and squamous cell carcinoma.

5

Patient Review

7/20/2022

Fluorouracil for Superficial Basal Cell Carcinoma of the Skin

I'm really confused by the negative reviews for this product. I followed the instructions to a T and found that it worked great for me. The spot turned red, scabbed over, and then disappeared. It was easy to use, painless, and avoided surgery.

5

Patient Review

2/12/2022

Fluorouracil for Roughened Red Patches of Skin due to Sun Exposure

Despite an initial breakout and some discomfort, this treatment really helped my skin regenerate. I would recommend using Aquaphor to help soothe the skin afterwards.

4.7

Patient Review

9/19/2022

Fluorouracil for Superficial Basal Cell Carcinoma of the Skin

I've been using this treatment on and off for a decade, and it really works wonders. I usually only do the full scalp treatment when absolutely necessary, as it can be painful. The process isn't pretty, but wearing a hat while you're out and about will help hide it from others until it's done. Once the treatment is finished, I make sure to keep an eye out for any dry or scabby patches so that I can spot treat them immediately.

4

Patient Review

10/7/2022

Fluorouracil for Superficial Basal Cell Carcinoma of the Skin

Just finished my six week treatment after only a small amount of cancer remained after removal. I was expecting the redness, itching, and tenderness, as well as the scales. The small discomfort wasn't bad at all. Been in the sun all my life. Now go out with long sleeve shirts that have UV protection. Bald head always has a hat, and will wear bucket for extra for head and ears. Sunscreen on ears, nose and anything exposed.

3

Patient Review

8/2/2022

Fluorouracil for Roughened Red Patches of Skin due to Sun Exposure

I unfortunately had pre-cancerous spots on my lips, so I began using the F. Cream. It's been a nightmare because it has made my lips incredibly sore and sensitive. Almost impossible to eat or drink without pain, and smiling is out of the question. One more week to go and hopefully this will be resolved.

1

Patient Review

2/4/2022

Fluorouracil for Roughened Red Patches of Skin due to Sun Exposure

I would never recommend this facial treatment to anyone. I went through the application process and recovery only to see a very small improvement. If you have a sedentary lifestyle, it may be OK (other than continuous sleepless nights). If you are an active, outdoors person, standby for "hell."
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about fluorouracil

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does fluorouracil do to your skin?

"This medication is used to treat pre-cancerous and cancerous skin growths by causing the death of abnormal cells."

Answered by AI

How long does it take for fluorouracil to start working?

"It usually takes at least 3 weeks for the medication to work, but it may take as long as 12 weeks. The skin around the area where the medication is applied will look red, swollen, and scaly during the first few weeks of treatment, which is a sign that the medication is working."

Answered by AI

What is fluorouracil used to treat?

"Fluorouracil topical is a medication used to treat actinic or solar keratoses and a type of skin cancer called superficial basal cell carcinoma. This medicine is available only with a doctor's prescription. This product is available in cream form."

Answered by AI

Is fluorouracil a chemotherapy drug?

"Fluorouracil belongs to a class of chemotherapy drugs called anti metabolites. Anti metabolites are similar to normal body molecules, but they have a slightly different structure. These differences mean that anti metabolites can inhibit the function of cancer cells."

Answered by AI

Clinical Trials for Fluorouracil

Image of Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University in Philadelphia, United States.

Contrast-Enhanced Ultrasound for Pancreatic Cancer

18+
All Sexes
Philadelphia, PA

This pilot study is testing whether a special type of ultrasound called contrast-enhanced ultrasound (CEUS) can help detect if pancreatic cancer has come back after surgery. People may be eligible to participate if they had surgery to remove pancreatic ductal adenocarcinoma (PDAC) from the head or body of the pancreas and are currently being monitored for cancer recurrence using CT scans. The study plans to enroll 10 participants: 5 people whose cancer has returned and 5 people whose cancer has not returned, based on their standard medical imaging results. Participants will not be randomly assigned to groups. Researchers will use a Logiq E10 ultrasound machine with CEUS technology to perform an ultrasound examination of the area where the surgery was performed. The goal is to determine whether CEUS can be a practical and useful tool for identifying local pancreatic cancer recurrence.

Recruiting
Has No Placebo

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Priscilla Machado, MD, FAIUM

Image of Memorial Sloan Kettering Basking Ridge (All Protocol Activities) in Basking Ridge, United States.

Ivermectin for Pancreatic Cancer

18+
All Sexes
Basking Ridge, NJ

The researchers are doing this study to find out whether the combination of ivermectin and standard of care prophylaxis (SOCP; drugs given to prevent the development of a disease or condition) is an effective treatment approach for people with skin side effects caused by daraxonrasib treatment (daraxonrasib-induced skin toxicity). The researchers will compare the combination of ivermectin and SOCP with SOCP alone to see which treatment approach is more effective. The researchers will also look at how the study treatments impact participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.

Phase 2
Recruiting

Memorial Sloan Kettering Basking Ridge (All Protocol Activities) (+6 Sites)

Allison Gordon, MD

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Image of Cedars-Sinai Medical Center in Los Angeles, United States.

Gemcitabine + Nab-paclitaxel ± L-glutamine for Pancreatic Cancer

18+
All Sexes
Los Angeles, CA

This is a multi-institution, open-label, two-arm, prospective randomized controlled phase I trial with the purpose to investigate the clinical efficacy of combination gemcitabine, nab-paclitaxel, and L-glutamine compared to gemcitabine and nab-paclitaxel alone in treatment-naïve, unresectable or metastatic pancreatic cancer. This study hypothesizes that combining L-glutamine with gemcitabine and nab-paclitaxel represents a superior therapeutic strategy over gemcitabine and nab-paclitaxel alone in the first-line treatment of advanced PDAC based on the positive results of the phase I GlutaPanc trial that demonstrated the feasibility and preliminary efficacy of combining glutamine supplementation with gemcitabine and nab-paclitaxel in the first-line treatment of advanced PDAC. This study also plans to characterize the safety and secondary endpoints of efficacy (ORR and PFS) of the combination in this cohort. Additionally, the study will characterize the anti-cachexia effects of the study combination compared to control through standard measures such as weight gain, weight stability, and body composition assessments. Lastly, this study will conduct correlative studies on study treatment impact on tumor metabolism, the gut microbiome composition and bacterial metabolism, the plasma and fecal metabolome, and inflammatory signaling, relative to control, to identify potential biomarkers to guide selection of candidates ideal for L-glutamine-based combination therapy.

Phase 2
Waitlist Available

Cedars-Sinai Medical Center

Jun Gong, MD

Image of Einstein College of Medicine/Montefiore Hospital in The Bronx, United States.

Lm-LLO-TT + Gemcitabine for Pancreatic Cancer

18+
All Sexes
The Bronx, NY

ClinicalTrials.gov Brief Summary This Phase 1, open-label, first-in-human study is designed to evaluate the safety, tolerability, and recommended dose of intraperitoneal (IP) administration of Lm-LLO-TT in combination with low-dose gemcitabine in adults with previously treated, unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC). Up to 18 participants will be enrolled. Lm-LLO-TT is a live attenuated Listeria monocytogenes-based immunotherapy engineered to express a tetanus toxoid antigen. The study will assess the safety of administering Lm-LLO-TT directly into the peritoneal cavity and characterize its use in combination with low-dose gemcitabine. Eligible participants will receive a tetanus toxoid booster vaccination during screening and undergo placement of an intraperitoneal access port before treatment. Participants will receive a single loading dose of Lm-LLO-TT followed by five cycles of low-dose gemcitabine and low-dose Lm-LLO-TT administered over approximately 17 days. Participants will be monitored for adverse events, laboratory abnormalities, dose-limiting toxicities, and disease outcomes throughout the study. The primary objective is to assess safety and tolerability and to determine the maximum tolerated dose and recommended dose for future clinical studies. Secondary objectives include evaluation of anti-tumor activity. Exploratory objectives include assessment of immune biomarkers, changes in pancreatic cancer-related symptoms, and changes in pain medication use. Participants will undergo tumor imaging assessments following treatment and during follow-up. A post-treatment tumor biopsy will be required for the first 10 enrolled participants and optional for subsequent participants. Participants will be followed for safety, disease status, and survival for up to 6 months after treatment initiation.

Phase 1
Recruiting

Einstein College of Medicine/Montefiore Hospital

Loki Therapeutics, Inc.

Image of University of Virginia Health System in Charlottesville, United States.

Avutometinib + Defactinib for Pancreatic Cancer

18+
All Sexes
Charlottesville, VA

The goal of this study is to find out if taking two oral study drugs (avutometinib and defactinib) are safe for patients with pancreatic ductal adenocarcinoma (PDAC). Researchers also want to see if the drugs can slow down tumor growth and shrink tumors for possible surgery. These drugs are approved by the FDA to treat a certain kind of ovarian cancer. This study has two parts: * Part A is for patients whose cancer has spread to other parts of the body. * Part B is for patients whose cancer has not spread, but who cannot have surgery. Participants will take both drugs as told by their doctor with their regular cancer medicine. Participants will also give blood samples throughout the study. These samples will help researchers learn about how participants respond to treatment and about their pancreatic cancer.

Phase 1 & 2
Waitlist Available

University of Virginia Health System

Matthew Reilley, MD

Verastem, Inc.

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MGC030 for Cancer

18+
All Sexes
Lake Success, NY

The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of MGC030. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors of select types. The main question the study aims to answer is: * What types of side effects will participants experience when receiving MGC030? * Can MGC030 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors? Participants will * Undergo screening procedures to determine eligibility * Receive study treatments initially every 3 weeks. * Have blood samples taken for routine and research tests * Have other examinations to check heart and lung function, and general health status * Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary. * Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.

Phase 1
Recruiting

START New York-Long Island

Frank Perabo, MD, PhD

MacroGenics

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