Clinical Trials

 

Improving the Safety of Fluoropyrimidine-based Chemotherapy by Combined DPYD Genotype-guided and DPD Phenotype-guided Dose Individualization: The ALPE2U Study

Intervention Type: Drug
Study Type: Interventional
Sponsors: The Netherlands Cancer Institute, Leiden University Medical Center
Participants: 1440
Abstract
In this study it will be determined whether the rate of severe toxicity associated with fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront phenotypic assessment of dihydropyrimidine dehydrogenase (DPD) deficiency.
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Facilities
Netherlands Cancer Institute - Antoni van Leeuwenhoek - Recruiting
Amsterdam, Netherlands
Contacts
Backup
Annemieke Cats, MD, PhD
a.cats@nki.nl
Primary
Jonathan Knikman, PharmD
j.knikman@nki.nl
+31 (0)20 512 9111
Eligibilities
Sex: All
Minimum Age: 18
Healthy Volunteers: No
Inclusion Criteria:
- Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient's best interest
- Patient need to be of Western descent
- Age ≥ 18
- Able and willing to give written informed consent
- WHO performance status of 0, 1 or 2
- Able and willing to undergo extra blood sampling for study related analysis
- Adequate baseline patient characteristics, in the opinion of the treating physician (complete blood count, hepatic function which involves serum bilirubin, AST, ALT, and renal function)
Exclusion Criteria:
- Prior treatment with fluoropyrimidines
- Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety in the opinion of the treating physician
- Patients treated with the combination of a fluoropyrimidine and irinotecan
Relevant Conditions

Low Potassium Level

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