#1 Clinical Trials Search in Europe

Oteracil

Oteracil, a component of several combination cancer drugs, is currently being studied in various clinical trials for its potential in treating different types of cancer. This article explores the ongoing research on Oteracil’s efficacy and safety in combination therapies for colorectal, gastric, esophageal, pancreatic, breast, and cervical cancers. We’ll examine the latest findings from these trials and what they mean for patients and the future of cancer treatment.

Table of Contents

What is Oteracil?

Oteracil is a medication that is often used in combination with other drugs to treat various types of cancer. It is typically found as part of a combination drug known as Tegafur-Gimeracil-Oteracil, which is also referred to as S-1 or TS-1[1][2]. This combination is designed to enhance the effectiveness of cancer treatment while potentially reducing some side effects.

How Oteracil Works

Oteracil is part of a class of drugs known as antimetabolites. When used in combination with Tegafur and Gimeracil, it helps to make cancer treatment more effective. Here’s a simplified explanation of how each component works:

  • Tegafur: This is converted in the body to 5-fluorouracil (5-FU), a substance that interferes with cancer cell growth.
  • Gimeracil: This helps maintain higher levels of 5-FU in the body by preventing its breakdown.
  • Oteracil: This component helps reduce some of the side effects of 5-FU by limiting its activity in normal gastrointestinal tissue[3].

Conditions Treated with Oteracil

Oteracil, as part of the S-1 combination, is used to treat several types of cancer, including:

  • Colorectal Cancer: This includes cancer of the colon or rectum[4].
  • Gastric Cancer: Also known as stomach cancer[5].
  • Pancreatic Cancer: Cancer that starts in the pancreas[6].
  • Esophageal Cancer: Cancer of the esophagus, particularly a type called esophageal squamous cell carcinoma[7].
  • Breast Cancer: Particularly in advanced or metastatic cases[4].
  • Cervical Cancer: Cancer that starts in the cervix[8].

Oteracil in Combination Therapies

Oteracil is often used in combination with other cancer treatments to enhance effectiveness. Some common combinations include:

  • S-1 (Tegafur-Gimeracil-Oteracil) with Fruquintinib: This combination is being studied for colorectal cancer[1].
  • S-1 with Bevacizumab: This combination is being investigated for colorectal cancer[9].
  • S-1 with Gemcitabine and Nivolumab: This combination is being studied for pancreatic cancer[6].
  • S-1 with Irinotecan and Oxaliplatin: This combination (called SIROX) is being investigated for pancreatic cancer[10].

Dosage and Administration

The dosage of Oteracil (as part of S-1) can vary depending on the specific condition being treated and the patient’s body surface area. It is typically taken orally (by mouth) in cycles. For example:

  • In some studies, S-1 is given for 2 weeks followed by a 1-week break, repeating every 3 weeks[1].
  • In other cases, it might be given for 4 weeks followed by a 2-week break[5].
  • The dose is often calculated based on body surface area, with typical ranges from 30mg to 60mg twice daily[7].

It’s crucial to follow your doctor’s instructions precisely when taking this medication.

Ongoing Clinical Trials

Several clinical trials are currently investigating the use of Oteracil (as part of S-1) for various cancers:

  • A study combining S-1 with Fruquintinib for colorectal cancer[1].
  • Research on S-1 as consolidation therapy after chemoradiotherapy for nasopharyngeal carcinoma[2].
  • A trial using S-1 after surgery and chemotherapy for gastric cancer[3].
  • Studies on S-1 in combination with immunotherapy drugs for esophageal cancer[7].

Potential Side Effects

Like all medications, Oteracil (as part of S-1) can cause side effects. Common side effects may include:

  • Nausea and vomiting
  • Diarrhea
  • Fatigue
  • Loss of appetite
  • Changes in blood cell counts

Your healthcare team will monitor you closely for these and other potential side effects. It’s important to report any unusual symptoms to your doctor promptly[4][4].

Cancer Type Drug Combination Trial Phase Primary Outcome
Colorectal Fruquintinib + Tegafur Gimeracil Oteracil II Progression-Free Survival
Nasopharyngeal Tegafur-Gimeracil-Oteracil II Distant Metastasis-Free Survival
Gastric Docetaxel + S-1 (Tegafur-Gimeracil-Oteracil) N/A Recurrence-Free Survival
Breast Tegafur Gimeracil Oteracil Potassium Capsule II Progression-Free Survival
Pancreatic Nivolumab + Gemcitabine + S-1 II Overall Response Rate
Esophageal Squamous Cell Fruquintinib + Cadonilimab + S-1 Ib/II Maximum Tolerated Dose, 16-Week PFS Rate
Cervical Chemoradiotherapy + S-1 N/A Progression-Free Survival

FAQ

  • What is Oteracil and how does it work in cancer treatment? Oteracil is a component of combination cancer drugs, often used with Tegafur and Gimeracil. It helps reduce the side effects of the active drug by inhibiting its action in normal gastrointestinal tissue, while allowing it to remain active against cancer cells.
  • In which types of cancer is Oteracil being studied? Oteracil is being studied in clinical trials for various cancers, including colorectal, gastric, esophageal, pancreatic, breast, and cervical cancers. It's often used in combination with other drugs to potentially improve treatment outcomes.
  • What are some common drug combinations that include Oteracil? Common combinations include Tegafur-Gimeracil-Oteracil (also known as S-1 or TS-1), often used with other drugs like Fruquintinib, Docetaxel, or Nivolumab, depending on the specific cancer type and treatment strategy.
  • What are the primary goals of the clinical trials involving Oteracil? The primary goals of these trials include assessing the efficacy and safety of Oteracil-containing combinations, measuring outcomes such as progression-free survival, overall survival, and response rates, and evaluating potential side effects.
  • How is Oteracil typically administered in these clinical trials? Oteracil is usually administered orally as part of a combination drug. The dosage and schedule can vary depending on the specific trial and cancer type, but it's often given in cycles with treatment periods followed by rest periods.

Ongoing Clinical Trials on Oteracil

  • Study Comparing Chemotherapy with Irinotecan, Folinic Acid, and Oxaliplatin for Patients with Locally Recurrent Rectal Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium The Netherlands Norway Portugal Sweden

  • Study on Using ctDNA to Guide Treatment in Patients with Metastatic Colorectal Cancer Using Oxaliplatin, Capecitabine, Calcium Folinate, Irinotecan, and Fluorouracil

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Germany Norway

  • Study of pembrolizumab, capecitabine, or olaparib in patients with early-stage triple negative breast cancer and remaining disease after initial treatment

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of Irinotecan with S1 or 5-Fluorouracil for Patients with Metastatic Pancreatic Cancer After Gemcitabine Treatment

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Italy The Netherlands Spain

  • Study on the Impact of DPYD Gene Test on the Safety and Efficacy of Fluorouracil, Capecitabine, and Tegafur in Finnish Patients with Breast or Colon Cancer

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

Glossary

  • Oteracil: A component of combination cancer drugs that helps reduce side effects by inhibiting the action of the active drug in normal gastrointestinal tissue while allowing it to remain active against cancer cells.
  • Tegafur: An oral prodrug of 5-fluorouracil (5-FU), used in combination cancer treatments. It's converted to 5-FU in the body to fight cancer cells.
  • Gimeracil: A drug used in combination with Tegafur and Oteracil to enhance the effectiveness of the treatment by inhibiting the breakdown of 5-FU in the body.
  • S-1 or TS-1: A combination drug containing Tegafur, Gimeracil, and Oteracil, used in various cancer treatments.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment that patients are still alive.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Disease Control Rate (DCR): The percentage of patients who have achieved complete response, partial response, or stable disease from treatment.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Chemoradiotherapy: A treatment that combines chemotherapy with radiation therapy.

References

  1. https://clinicaltrials.gov/study/NCT06255379
  2. https://clinicaltrials.gov/study/NCT03904225
  3. https://clinicaltrials.gov/study/NCT05813015
  4. https://clinicaltrials.gov/study/NCT01492543
  5. https://clinicaltrials.gov/study/NCT00503321
  6. https://clinicaltrials.gov/study/NCT04377048
  7. https://clinicaltrials.gov/study/NCT06487702
  8. https://clinicaltrials.gov/study/NCT04310774
  9. https://clinicaltrials.gov/study/NCT00974389
  10. https://clinicaltrials.gov/study/NCT03316326