#1 Clinical Trials Search in Europe

Capecitabine

Capecitabine is an oral chemotherapy drug being studied in various clinical trials for different types of cancer. These trials aim to evaluate its effectiveness, safety, and optimal dosing when used alone or in combination with other treatments. The research focuses on cancers such as rectal, gastric, biliary tract, and breast cancer, exploring capecitabine’s potential in neoadjuvant, adjuvant, and metastatic settings.

Table of Contents

What is Capecitabine?

Capecitabine, also known by its brand names Xeloda or Xeloda, is an oral medication used in cancer treatment[1]. It belongs to a class of drugs called fluoropyrimidine carbamates, which are designed to interfere with cancer cell growth[2]. Capecitabine is what’s known as a prodrug, which means it’s inactive when you take it, but your body converts it into an active form of the medication called fluorouracil (5-FU) once it reaches the tumor site[1].

What Conditions Does Capecitabine Treat?

Capecitabine is used to treat several types of cancer, including:

  • Colorectal Cancer: Including metastatic colorectal cancer (cancer that has spread to other parts of the body)[3]
  • Breast Cancer: Particularly HER2+ metastatic breast cancer[1]
  • Gastric (Stomach) Cancer: Including advanced and metastatic forms[2]
  • Gastroesophageal Junction Adenocarcinoma: Cancer that occurs where the esophagus meets the stomach[2]
  • Anal Canal Cancer: Used in combination with other treatments[4]

How Does Capecitabine Work?

Capecitabine works by interfering with the DNA production of cancer cells. When you take the medication, your body converts it into 5-FU at the tumor site. This active form of the drug then blocks an enzyme called thymidylate synthase, which is necessary for DNA replication. By doing this, capecitabine stops cancer cells from dividing and growing[2].

In some treatment regimens, capecitabine is used in a “metronomic” approach. This means it’s given in lower doses but more frequently, which may help to prevent the growth of blood vessels that feed tumors (a process called angiogenesis)[3].

How is Capecitabine Administered?

Capecitabine is taken orally in the form of tablets. The dosage and schedule can vary depending on the specific treatment plan, but some common approaches include:

  • Twice daily dosing, often for 14 days followed by a 7-day rest period[1]
  • Continuous daily dosing in some metronomic regimens[3]
  • Dosages are typically calculated based on body surface area (BSA)[2]

It’s important to take capecitabine exactly as prescribed by your doctor. The tablets should be swallowed whole with water within 30 minutes after a meal[1].

Capecitabine in Combination Therapies

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

  • Capecitabine + Docetaxel: Used in treating advanced gastric cancer[2]
  • Capecitabine + Oxaliplatin + Irinotecan + Bevacizumab: Used in treating colorectal cancer liver metastases[5]
  • Capecitabine + Mitomycin + Panitumumab: Used with radiation therapy in treating anal canal cancer[4]
  • Capecitabine + Neratinib or Lapatinib: Used in treating HER2+ metastatic breast cancer[1]

Potential Side Effects

Like all medications, capecitabine can cause side effects. Some common side effects may include:

  • Diarrhea
  • Nausea and vomiting
  • Hand-foot syndrome (redness, swelling, and pain on the palms of hands and soles of feet)
  • Fatigue
  • Loss of appetite

Your healthcare team will monitor you closely for these and other potential side effects. It’s important to report any new symptoms or changes in your health to your doctor promptly[1].

Ongoing Research and Clinical Trials

Researchers continue to study capecitabine to find new ways to use it effectively. Some areas of ongoing research include:

  • Using capecitabine in combination with immunotherapy drugs like avelumab for treating rectal cancer[6]
  • Exploring metronomic dosing of capecitabine in various cancer types[3]
  • Investigating capecitabine as part of perioperative treatment (treatment given before and after surgery) for colorectal cancer liver metastases[5]
  • Studying capecitabine in combination with newer targeted therapies for breast cancer[1]

These ongoing studies aim to improve the effectiveness of capecitabine and expand its use to benefit more patients with various types of cancer.

Aspect Details
Cancer Types Studied Rectal cancer, gastric cancer, biliary tract cancer, triple-negative breast cancer
Treatment Settings Neoadjuvant (before surgery), adjuvant (after surgery), metastatic disease
Combination Therapies Radiotherapy, other chemotherapy drugs (e.g., gemcitabine, oxaliplatin), targeted therapies (e.g., bevacizumab, trastuzumab)
Dosing Strategies Standard dosing (e.g., 1000-1650 mg/m2/day), metronomic dosing (e.g., 650 mg/m2 twice daily for 1 year)
Primary Outcomes Progression-free survival, pathological complete response, disease-free survival
Secondary Outcomes Overall survival, tumor response rate, toxicity profile, quality of life
Patient Populations Various age groups, including elderly patients (over 70 years old in some studies)
Trial Phases Phase I, II, and III studies represented

FAQ

  • What is capecitabine and how does it work? Capecitabine is an oral chemotherapy drug that is converted to 5-fluorouracil (5-FU) in the body. It works by interfering with cancer cell growth and division, ultimately leading to cell death.
  • What types of cancer are being studied with capecitabine? Clinical trials are exploring capecitabine's use in various cancers, including rectal cancer, gastric cancer, biliary tract cancer, and triple-negative breast cancer.
  • How is capecitabine administered in these trials? Capecitabine is typically given orally in tablet form. The dosage and schedule vary depending on the specific trial and cancer type, but it's often taken twice daily for a certain number of days in each treatment cycle.
  • What are some common side effects of capecitabine? Common side effects may include hand-foot syndrome (redness, swelling, and pain on the palms and soles), diarrhea, nausea, vomiting, fatigue, and decreased blood cell counts. The severity and frequency of side effects can vary depending on the dosage and individual patient factors.
  • How long do patients typically receive capecitabine treatment in these trials? The duration of capecitabine treatment varies widely depending on the trial design and cancer type. Some studies use it for a fixed number of cycles (e.g., 6-8 cycles), while others may continue treatment for up to a year or until disease progression or unacceptable toxicity occurs.

Ongoing Clinical Trials on Capecitabine

  • Study of Zanidatamab and Tislelizumab Combined with Chemotherapy for Patients with Advanced or Metastatic HER2-positive Gastroesophageal Cancer

    Not recruiting

    3 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Belgium Estonia France Germany Greece Ireland +6

  • Study Comparing FOLFOX Before Surgery to Risk-Adapted Chemotherapy After Surgery for Patients with Locally Advanced Rectal Cancer and Low Risk of Local Failure

    Not recruiting

    3 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Germany

  • Study on Gemcitabine and Cisplatin for Patients After Surgery for Bile Duct or Gallbladder Cancer

    Not recruiting

    3 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Austria Germany Italy The Netherlands

  • Study of organ preservation using chemoradiotherapy and transanal surgery compared to standard surgery in patients with early rectal cancer (STAR-TREC trial)

    Not recruiting

    4 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Belgium The Netherlands Sweden

  • Study on the Effectiveness of FOLFOX and Panitumumab for Patients with Metastatic Colorectal Cancer Without RAS Mutation

    Not recruiting

    2 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Belgium France

  • Study of MK-7684A and Pembrolizumab for Patients with Advanced Solid Tumors

    Not recruiting

    2 1 1 1
    Investigated Drugs:
    France Germany Italy The Netherlands Poland Spain

  • Study of Bemarituzumab with Chemotherapy and Nivolumab in Untreated Advanced Gastric and Gastroesophageal Junction Cancer Patients with FGFR2b Overexpression

    Not recruiting

    3 1 1
    Investigated Drugs:
    Austria Belgium Bulgaria Czechia France Germany +6

  • Study Comparing DB-1303 and Chemotherapy for Patients with HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

    Not recruiting

    3 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Belgium France Germany Hungary Italy Poland +1

  • Study of Datopotamab Deruxtecan and Durvalumab for Adults with Untreated Triple-Negative or Hormone Receptor-Low/HER2-Negative Breast Cancer

    Not recruiting

    3 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Austria Belgium Bulgaria France Germany Hungary +3

  • Study of Durvalumab with Chemoradiation Therapy for Patients with Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma

    Not recruiting

    3 1 1
    Investigated Diseases:
    Investigated Drugs:
    Belgium France Poland Spain

Glossary

  • Neoadjuvant therapy: Treatment given before the main treatment, usually before surgery, to shrink the tumor and make it easier to remove or treat.
  • Adjuvant therapy: Additional treatment given after the primary treatment (usually surgery) to lower the risk of cancer coming back.
  • Pathological complete response (pCR): The absence of any detectable cancer cells in the tissue removed during surgery after neoadjuvant therapy.
  • Metastatic cancer: Cancer that has spread from its original site to other parts of the body.
  • Progression-free survival: The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Overall survival: The length of time from the start of treatment or diagnosis that patients are still alive.
  • Dose-limiting toxicity: Side effects severe enough to prevent an increase in the dose of a drug or that require a reduction in the dose.
  • HER2: Human Epidermal Growth Factor Receptor 2, a protein that can play a role in the development of some breast cancers.
  • Triple-negative breast cancer: A type of breast cancer that lacks receptors for estrogen, progesterone, and HER2, making it more challenging to treat.
  • Metronomic chemotherapy: A method of giving low doses of chemotherapy drugs on a frequent or continuous schedule, with the aim of reducing side effects while maintaining effectiveness.

References

  1. https://clinicaltrials.gov/study/NCT01808573
  2. https://clinicaltrials.gov/study/NCT02007148
  3. https://clinicaltrials.gov/study/NCT01668680
  4. https://clinicaltrials.gov/study/NCT01843452
  5. https://clinicaltrials.gov/study/NCT02086656
  6. https://clinicaltrials.gov/study/NCT03854799