Overview

Improving the Safety of Fluoropyrimidine-based Chemotherapy

Status:
Recruiting

Trial end date:
2021-01-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The Netherlands Cancer Institute

Collaborator:

Leiden University Medical Center

Treatments:

Capecitabine
Fluorouracil

Criteria

Inclusion Criteria:

1. Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is
considered to be in the patient's best interest

2. Patient need to be of Western descent

3. Age ≥ 18

4. Able and willing to give written informed consent

5. WHO performance status of 0, 1 or 2

6. Able and willing to undergo extra blood sampling for study related analysis

7. 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:

1. Prior treatment with fluoropyrimidines

2. 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

3. Patients treated with the combination of a fluoropyrimidine and irinotecan