Actively Recruiting
Exploratory Study of Capecitabine Pharmacokinetics and Hand-foot Syndrome in CES1 Variant Carriers: the ESCAPE Study
Led by Erasmus Medical Center · Updated on 2025-08-11
66
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the enzyme CES1 affects the way the drug capecitabine is processed in the body of cancer patients. Capecitabine is a common oral treatment for breast, colon, stomach, and other solid cancers. The study focuses on whether patients with a less effective CES1 enzyme have higher blood levels of the active drug molecule 5-FU and whether these patients experience more side effects like hand-foot syndrome, which causes redness and pain in the hands and feet. This research aims to better understand the causes of side effects related to capecitabine use. The study observes cancer patients treated with capecitabine combined with oxaliplatin (CAPOX), sometimes alongside other anti-cancer drugs such as nivolumab, trastuzumab, or bevacizumab. Participants are grouped based on whether they carry a specific variant or the normal form of the CES1 gene. Extra blood samples will be collected to measure how capecitabine is metabolized in the body, focusing on the first 6 hours after taking the drug. Participants will be monitored for the amount of 5-FU in their blood and for side effects like hand-foot syndrome. Researchers will collect blood samples during treatment and assess patient health and side effects. The study involves adults who are starting standard treatment with capecitabine and oxaliplatin. The total participation time includes the initial treatment phase and follow-up assessments to understand the link between CES1 enzyme function and drug exposure.
CONDITIONS
Brief Title
Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Planned to start treatment with concomitant capecitabine and oxaliplatin according to standard of care
- 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
You will not qualify if you...
- Carrier of a known clinically relevant DPYD variant (i.e. *2A, *7, *13, c.1236G>A or c.2846A>T)
- Any medical condition that is known to influence capecitabine absorption (e.g. Roux-en-Y gastric bypass or complete gastric resection; esophagectomy is allowed)
- Prior treatment with fluoropyrimidines
- Use of DPD-inhibitors and/or allopurinol
- Known pregnancy at baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 hours after intake of capecitabine
Participants treated with capecitabine and oxaliplatin according to standard care are observed with extra blood samples collected for pharmacokinetic assessment.
1 visit (in-person) for blood sampling
Trial Site Locations
Total: 1 location
1
Erasmus MC Cancer Institute
Rotterdam, Netherlands, 3015GD
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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