Improving the Safety of Fluoropyrimidine-based Chemotherapy

Last updated: January 20, 2020
Sponsor: The Netherlands Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT04194957
M19ALP
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pathologically confirmed malignancy for which treatment with a fluoropyrimidine isconsidered 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, andrenal function)

Exclusion

Exclusion Criteria:

  1. Prior treatment with fluoropyrimidines

  2. Patients with known substance abuse, psychotic disorders, and/or other diseasesexpected to interfere with study or the patient's safety in the opinion of thetreating physician

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

Study Design

Total Participants: 1440
Study Start date:
January 15, 2020
Estimated Completion Date:
January 31, 2021

Study Description

In this study a phenotypic approach will be studied to determine the additional value of pretreatment uracil level-guided dose individualization in wildtype patients. Patients with a pretreatment serum uracil concentration above 16 ng/ml will be treated with a 50% reduced fluoropyrimidine starting dose. The pretreatment serum uracil levels in DPYD variant carriers will be assessed retrospectively and non-interventional. Additionally, the effect of a higher dose reduction in c.1236G>A and c.2846A>T DPYD variants carriers (50% instead of 25%) will be studied.

Connect with a study center

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek

    Amsterdam,
    Netherlands

    Active - Recruiting

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