Exploratory Study of CAPEcitabine pharmacokinetics and hand-foot syndrome in CES1 variant carriers: the ESCAPE study

Conditions

Locally advanced or metastatic gastro-intestinal carcinoma

Brief summary

• Difference in AUC0-6 of 5-FU among carriers vs wildtypes for CES1 1165–33 C>A (rs2244613) on C1D14

Detailed description

Difference in AUC0-6 of capecitabine and its metabolites besides 5-FU (e.g. capecitabine, 5DFCR, 5DFUR, DHFU, FBAL and FAC) among carriers vs wildtypes for CES1 1165–33 C>A (rs2244613) on C1D14, Differences in concentrations of 5-FU and other metabolites in dermal biopsies and urine among carriers vs wildtypes for CES1 1165–33 C>A (rs2244613) on C1D14, Genotyping of SNPs in genes related to the metabolic pathway of capecitabine (including but not limited to CES1, CES2, CDA, TP, DPYD, DPYS, PPAR-delta), in association with PK and toxicity, Incidence of toxicity for the respective subgroups, HFS-14 questionnaire scores, Differences in the pharmacokinetics of oxaliplatin, in relation with pharmacogenetics and the development of toxicity using plasm concentrations measured on C1D1 (post-infusion) and on C1D14

Related papers

No related papers found yet.

Interventions

DRUGOXALIPLATIN

DRUGCAPECITABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Difference in AUC0-6 of 5-FU among carriers vs wildtypes for CES1 1165–33 C>A (rs2244613) on C1D14	—

Secondary

Measure	Time frame
Difference in AUC0-6 of capecitabine and its metabolites besides 5-FU (e.g. capecitabine, 5DFCR, 5DFUR, DHFU, FBAL and FAC) among carriers vs wildtypes for CES1 1165–33 C>A (rs2244613) on C1D14, Differences in concentrations of 5-FU and other metabolites in dermal biopsies and urine among carriers vs wildtypes for CES1 1165–33 C>A (rs2244613) on C1D14, Genotyping of SNPs in genes related to the metabolic pathway of capecitabine (including but not limited to CES1, CES2, CDA, TP, DPYD, DPYS, PPAR-delta), in association with PK and toxicity, Incidence of toxicity for the respective subgroups, HFS-14 questionnaire scores, Differences in the pharmacokinetics of oxaliplatin, in relation with pharmacogenetics and the development of toxicity using plasm concentrations measured on C1D1 (post-infusion) and on C1D14	—

Measure

Time frame

Difference in AUC0-6 of capecitabine and its metabolites besides 5-FU (e.g. capecitabine, 5DFCR, 5DFUR, DHFU, FBAL and FAC) among carriers vs wildtypes for CES1 1165–33 C>A (rs2244613) on C1D14, Differences in concentrations of 5-FU and other metabolites in dermal biopsies and urine among carriers vs wildtypes for CES1 1165–33 C>A (rs2244613) on C1D14, Genotyping of SNPs in genes related to the metabolic pathway of capecitabine (including but not limited to CES1, CES2, CDA, TP, DPYD, DPYS, PPAR-delta), in association with PK and toxicity, Incidence of toxicity for the respective subgroups, HFS-14 questionnaire scores, Differences in the pharmacokinetics of oxaliplatin, in relation with pharmacogenetics and the development of toxicity using plasm concentrations measured on C1D1 (post-infusion) and on C1D14

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Countries

Netherlands

Outcome results

None listed