#1 Clinical Trials Search in Europe

Gimeracil

Gimeracil, a component of the drug combination S-1 (also known as Tegafur-Gimeracil-Oteracil), is being studied in various clinical trials for its potential in treating different types of cancer. These trials aim to evaluate the efficacy and safety of Gimeracil-containing treatments, either alone or in combination with other drugs, in patients with advanced or metastatic cancers such as colorectal, gastric, pancreatic, breast, and esophageal cancers.

Table of Contents

What is GIMERACIL?

GIMERACIL is a component of a combination drug therapy known as S-1 or TS-1. This medication is typically combined with two other drugs: Tegafur and Oteracil Potassium. Together, these three components form a novel oral anticancer treatment[1].

S-1 (also known as Tegafur-Gimeracil-Oteracil) is a type of chemotherapy drug that belongs to the class of medications called antimetabolites. It works by interfering with the growth of cancer cells, ultimately leading to their destruction[2].

Conditions Treated with GIMERACIL

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

  • Colorectal Cancer: S-1 is used in the treatment of advanced or metastatic colorectal cancer, especially when other treatments have failed[3].
  • Gastric Cancer: It’s approved for the treatment of advanced gastric (stomach) cancer in some countries[4].
  • Pancreatic Cancer: S-1 is being studied for use in metastatic pancreatic cancer[2].
  • Breast Cancer: Clinical trials have explored its use in advanced metastatic breast cancer[1].
  • Esophageal Cancer: It’s being investigated for use in advanced or metastatic esophageal squamous cell carcinoma[5].
  • Cervical Cancer: Studies are ongoing to evaluate its efficacy in locally advanced cervical cancer[6].

Combination Therapies

GIMERACIL, as part of S-1, is often used in combination with other cancer treatments to enhance its effectiveness. Some common combinations include:

  • S-1 with Bevacizumab: This combination is being studied for colorectal cancer treatment[7].
  • S-1 with Gemcitabine: Used in pancreatic cancer treatment[2].
  • S-1 with Docetaxel: Being studied for gastric cancer treatment[4].
  • S-1 with Fruquintinib and Cadonilimab: This triple combination is being investigated for esophageal cancer[5].

Dosage and Administration

The dosage of S-1 (which contains GIMERACIL) can vary depending on the specific condition being treated and the patient’s body surface area (BSA). Here are some general guidelines:

  • For patients with BSA less than 1.25 m², the typical dose is 40 mg twice daily.
  • For patients with BSA between 1.25 m² and 1.5 m², the dose is usually 50 mg twice daily.
  • For patients with BSA greater than 1.5 m², the dose may be 60 mg twice daily[3].

S-1 is typically taken orally, twice daily, for 14 days followed by a 7-day rest period. This 21-day cycle is then repeated[2]. However, the exact schedule can vary depending on the treatment plan and combination with other drugs.

Current Clinical Trials

Several clinical trials are currently underway to further investigate the efficacy of GIMERACIL (as part of S-1) in various cancers:

  • A study combining S-1 with Fruquintinib for metastatic colorectal cancer[3].
  • An investigation of S-1 as consolidation therapy after chemoradiotherapy in cervical cancer[6].
  • A trial exploring S-1 with Gemcitabine and Nivolumab in metastatic pancreatic cancer[2].
  • A study of S-1 combined with Fruquintinib and Cadonilimab in esophageal cancer[5].

Potential Side Effects

Like all medications, S-1 (containing GIMERACIL) can cause side effects. Common side effects may include:

  • Nausea and vomiting
  • Diarrhea
  • Fatigue
  • Loss of appetite
  • Lowered blood cell counts, which can increase the risk of infection or bleeding

It’s important to note that not everyone experiences these side effects, and your healthcare provider will monitor you closely during treatment[6].

Aspect Details
Cancer Types Studied Colorectal, gastric, pancreatic, breast, esophageal, nasopharyngeal, cervical
Common Drug Combinations S-1 (Tegafur-Gimeracil-Oteracil), often combined with other drugs like Bevacizumab, Fruquintinib, or immunotherapy agents
Administration Typically oral, with dosages based on body surface area; common schedules include 2-4 weeks on, followed by a rest period
Primary Outcomes Measured Progression-free survival, overall response rate, disease control rate, overall survival
Potential Benefits Improved survival rates, tumor shrinkage, disease control in advanced cancers
Common Side Effects Nausea, vomiting, diarrhea, fatigue, decreased blood cell counts
Trial Phases Mostly Phase II, some Phase Ib/II combinations

FAQ

  • What is Gimeracil and how does it work? Gimeracil is a component of the drug combination S-1, which also includes Tegafur and Oteracil. It works by inhibiting an enzyme that breaks down 5-fluorouracil (5-FU), a cancer-fighting drug. This helps maintain higher levels of 5-FU in the body, potentially improving its effectiveness against cancer cells.
  • What types of cancer are being studied with Gimeracil-containing treatments? Clinical trials are exploring the use of Gimeracil-containing treatments in various cancers, including colorectal cancer, gastric (stomach) cancer, pancreatic cancer, breast cancer, and esophageal cancer.
  • How is Gimeracil typically administered in these clinical trials? Gimeracil is usually given as part of the S-1 combination, which is taken orally. The dosage and schedule can vary depending on the specific trial and the patient's body surface area. Common schedules include taking the medication for 2-4 weeks, followed by a rest period.
  • What are some common side effects of Gimeracil-containing treatments? While side effects can vary, some common ones may include nausea, vomiting, diarrhea, fatigue, and decreased blood cell counts. It's important to note that side effects can differ based on the specific treatment combination and individual patient factors.
  • Are there any promising results from these clinical trials? Some trials have shown promising results in terms of improved progression-free survival and overall response rates in certain cancer types. However, it's important to remember that clinical trials are ongoing, and more research is needed to fully understand the benefits and risks of Gimeracil-containing treatments.

Ongoing Clinical Trials on Gimeracil

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

    Recruiting

    1 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

    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

    1 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

    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

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

Glossary

  • Gimeracil: A component of the drug combination S-1 that helps maintain higher levels of the cancer-fighting drug 5-fluorouracil in the body.
  • S-1: An oral anticancer drug combination containing Tegafur, Gimeracil, and Oteracil, used in the treatment of various types of cancer.
  • Metastatic cancer: Cancer that has spread from its original site to other parts of the body.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Disease control rate (DCR): The percentage of patients who have a complete response, partial response, or stable disease after treatment.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Chemoradiotherapy: A treatment that combines chemotherapy with radiation therapy.
  • Adjuvant therapy: Additional cancer treatment given after the primary treatment to lower the risk of cancer coming back.
  • Body surface area (BSA): A calculated measure of body size used to determine dosages of medications, often based on a patient's height and weight.

References

  1. https://clinicaltrials.gov/study/NCT01492543
  2. https://clinicaltrials.gov/study/NCT04377048
  3. https://clinicaltrials.gov/study/NCT06255379
  4. https://clinicaltrials.gov/study/NCT05813015
  5. https://clinicaltrials.gov/study/NCT06487702
  6. https://clinicaltrials.gov/study/NCT04310774
  7. https://clinicaltrials.gov/study/NCT00974389