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Study of Capecitabine for Patients with Recurrent or Metastatic Salivary Duct Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer known as Salivary Duct Carcinoma, which affects the salivary glands. The trial is investigating the effects of a medication called Capecitabine. This medication is taken orally and is being tested to see how well it works for patients with this specific type of cancer that has either returned or spread to other parts of the body.

The purpose of the study is to evaluate the overall response rate to Capecitabine in treating recurrent or metastatic salivary duct carcinoma. Participants in the study will receive the medication over a period of time, and researchers will monitor their response to the treatment. The study aims to gather information on how the cancer responds to the medication, how long patients can live without the disease getting worse, and the overall survival rate. Additionally, the study will assess the safety of the medication and its impact on the quality of life of the participants.

Throughout the study, researchers will collect data to understand the clinical benefits and control of the disease provided by Capecitabine. The trial is expected to continue until the end of 2029, with recruitment of participants starting in early 2025. This research is important for finding new ways to manage and treat salivary duct carcinoma, especially for those whose cancer has not responded to other treatments.

1 initial assessment

Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of recurrent or metastatic salivary duct carcinoma.

The assessment ensures adequate kidney, liver, and bone marrow function. Blood tests are performed to check these functions.

Eligibility also requires progression on certain therapies or being unfit for them, and the presence of measurable disease or bone metastases.

2 consent and documentation

Written informed consent is required to participate in the trial. This document outlines the trial’s purpose, procedures, and potential risks and benefits.

Participants must be at least 18 years old and have an ECOG performance status of 0-1, indicating full activity or some symptoms but nearly fully ambulatory.

3 treatment phase

The treatment involves taking capecitabine orally. The specific dosage and frequency are determined by the trial protocol and the participant’s health status.

Capecitabine is a medication used to treat certain types of cancer by interfering with the growth of cancer cells.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and clinical evaluations.

Participants are monitored for any side effects or adverse reactions to the medication.

5 evaluation of outcomes

The primary outcome measured is the best overall response rate, which evaluates how well the cancer responds to the treatment.

Secondary outcomes include progression-free survival, overall survival, clinical benefit rate, disease control rate, safety, and quality of life.

6 completion and final assessment

The trial is estimated to end by December 31, 2029. A final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of Salivary Duct Carcinoma that cannot be cured.
  • Must have adequate kidney function, which means the kidneys are working well enough. This is checked by measuring a substance in the blood called serum creatinine. It should be no more than 1.5 times the normal level, or the kidneys should clear at least 30 milliliters per minute.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • If the cancer is AR+ HER2-, the patient must have shown disease progression despite treatment or be unwilling to receive a treatment called androgen blockade.
  • If the cancer is AR+ HER2+, the patient must have shown disease progression despite treatment with anti-HER2 therapy and androgen blockade, or be unwilling to receive androgen blockade.
  • Must have shown disease progression after treatment with carboplatin-paclitaxel or be unable to receive this treatment.
  • Must have a disease that can be measured according to specific guidelines (RECIST v1.1) or have only bone metastases that do not meet these guidelines.
  • Must be 18 years or older.
  • Must have an ECOG performance status of 0-1, which means being fully active or having some symptoms but still able to carry out light work.
  • Must have adequate bone marrow function, which means having enough healthy blood cells. This is checked by measuring neutrophils (a type of white blood cell), platelets (cells that help with blood clotting), and hemoglobin (a protein in red blood cells).
  • Must have adequate liver function, which means the liver is working well enough. This is checked by measuring substances in the blood like total bilirubin and liver enzymes called ALT and AST. Different levels are allowed for patients with a condition called Gilbert’s Syndrome or those with liver metastases.

Who Cannot Join the Study?

  • Patients with a different type of cancer than Salivary Duct Carcinoma cannot participate. This is a specific type of cancer that affects the salivary glands.
  • Individuals who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Participants who are part of a vulnerable population are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Stichting Radboud University Medical Center Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.03.2025

Trial locations

Investigated drugs:

Capecitabine is a medication used in this trial to treat patients with recurrent or metastatic salivary duct carcinoma. It is a type of chemotherapy that works by interfering with the growth of cancer cells, slowing their spread in the body. Capecitabine is often used when other treatments have not been successful, and it is taken orally in the form of a pill. The goal of using capecitabine in this trial is to evaluate its effectiveness in improving the overall response rate in patients with this type of cancer.

Investigated diseases:

Salivary Duct Carcinoma – This is a rare type of cancer that originates in the ducts of the salivary glands. It typically presents as a rapidly growing mass in the mouth or neck area. The disease can cause symptoms such as pain, swelling, and difficulty swallowing. As it progresses, it may invade nearby tissues and potentially spread to other parts of the body. Salivary duct carcinoma is known for its aggressive nature and tendency to recur after treatment. It is more commonly diagnosed in older adults and is often associated with a poor prognosis.

Trial ID:
2024-516956-16-01
Protocol code:
116162
Trial Phase:
Therapeutic use (Phase IV)

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