Exploratory Study of Capecitabine Pharmacokinetics and Hand-foot Syndrome in CES1 Variant Carriers: the ESCAPE Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

In this study, the drug capecitabine is investigated. Capecitabine is commonly used to treat breast, colon, and stomach cancers. Capecitabine is taken in tablet form. In the body, capecitabine is converted into the active molecule that has anti-cancer effects. This molecule is called 5-FU. The transformation of capecitabine to 5-FU occurs through specific proteins in the liver, also known as enzymes. Unfortunately, capecitabine can also cause side effects. One of the most common side effects is hand-foot syndrome. In hand-foot syndrome, the palms of the hands and soles of the feet become red and painful. Previous research has shown that patients in whom one of the enzymes responsible for converting capecitabine in the liver does not function properly experience an increase in side effects frequency, particularly severe hand-foot syndrome. This specific enzyme is called CES1. It is believed that side effects occur more frequently because capecitabine is transformed more slowly, eventually leading to a prolonged exposure to 5-FU in the body. In roughly one in three people, this enzyme functions less efficiently. To gain a better understanding of how this mechanism works, we aim to conduct this study. In this study, we will examine if patients with a less effective CES1 enzyme have higher amounts of 5-FU in their blood. We will also look into whether these patients develop side effects, such as hand-foot syndrome, more frequently. This information could eventually help us develop new strategies to reduce side effects for these patients in the future.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
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⁃ In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• 18 years of age or older;

• Planned to start treatment with concomitant capecitabine and oxaliplatin according to standard of care (irrespective of dose);

• Fit for treatment with capecitabine and oxaliplatin as judged by the treating physician;

• Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form.

Locations
Other Locations
Netherlands
Erasmus MC Cancer Institute
RECRUITING
Rotterdam
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2027-06
Participants
Target number of participants: 66
Treatments
Single-nucleotide polymorphism (SNP)
Oncological patients who are treated with CAPOX (with or without additional anti-neoplastic agents, including but not limited to nivolumab, trastuzumab or bevacizumab) according to standard of care. These patients are known carriers of the CES1 1165-33 C\>A (rs2244613) SNP.
Wild type
Oncological patients who are treated with CAPOX (with or without additional anti-neoplastic agents, including but not limited to nivolumab, trastuzumab or bevacizumab) according to standard of care. These patients are known carriers of the wild-type CES1 gene.
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov