Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Capecitabine

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Patients are screened for a DPD-deficiency. Patients with a DPYD\*2A mutation are eligible for intervention with capecitabine/5-FU .

Patients to treat with capecitabine/5-FU will be screened prior to start of therapy for DPYD\*2A. Patients heterozygous or homozygous mutant for DPYD\*2A receive dose reductions of capecitabine/5-FU of at least 50% in the first two courses. In case this dose is tolerated well, doses will be increased.

In addition, the pharmacokinetics of capecitabine/5-FU and their metabolites will be assessed in these patients.

Capecitabine, 5-fluorouracil

Jan HM Schellens, MD, PhD

The primary purpose of this study is to prospectively determine whether capecitabine and 5-FU-induced toxicity is preventable by dose reduction prior to start of the first administration in patients heterozygous or homozygous mutant for DPYD\*2A, and to determine whether this strategy is cost-effective. Secondly, an individualized treatment algorithm for capecitabine and 5-FU therapy in DPYD\*2A mutant patients will be developed and the pharmacokinetic profile of capecitabine and 5-FU will be assessed.

Patients exhibiting a genetically determined disorder (DPYD\*2A) in the metabolic degradation of the frequently used anticancer agents capecitabine and 5-FU (fluoropyrimidines) are at high risk of development of severe and life-threatening toxicity during standard treatment with these compounds. Treatment and recovery of this fluoropyrimidine-induced severe toxicity often requires prolonged periods of hospitalization.

Screening for DPYD\*2A in patients to treat with fluoropyrimidine drugs with subsequent dose adjustments in mutant individuals prior to start of therapy will possibly reduce the number of severe toxicity events. Furthermore, by reducing the frequency and/or duration of hospitalization, substantial medical costs can be saved, making this a cost-effective strategy.

Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines

The Netherlands Cancer Institute

Prof. dr. J.H.M. Schellens

Amino Acids

Paclitaxel

Albumin-Bound Paclitaxel

Busulfan

Afatinib

Crizotinib

Lapatinib

Imatinib Mesylate

Ceritinib

Tubulin Modulators

Antimitotic Agents

Alkylating Agents

Antineoplastic Agents, Alkylating

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

The use of antineoplastic agents depends on the clinical practice.

Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)

Zhao Wei, Ph.D

The purpose is to study the population pharmacokinetics, effectiveness and safety of antineoplastic drugs (Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc) in elderly patients and recommend optimized dosage regimens.

Antineoplastic Drugs in Elderly Patients

Population Pharmacokinetics, Effectiveness and Safety of Antineoplastic Drugs in Elderly Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines	NCT00838370	Neoplasms	Capecitabine, 5...	18 Years -	The Netherlands Cancer Institute
Antineoplastic Drugs in Elderly Patients	NCT05467189	Cancer	Busulfan, Pacli...	65 Years - 100 Years	Shandong University
Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines	NCT00838370	Neoplasms	Capecitabine, 5...	18 Years -	The Netherlands Cancer Institute
Antineoplastic Drugs in Elderly Patients	NCT05467189	Cancer	Busulfan, Pacli...	65 Years - 100 Years	Shandong University

Spots Global Cancer Trial Database for antineoplastic drugs