Personalized dosing of FOLFIRINOX in pancreatic cancer patients: a phase-2 pharmacokinetic, safety and feasibility trial

Conditions

Pancreatic cancer

Brief summary

Percentage of patients undergoing FOLFIRINOX treated with standard-dosed (BSA) 5-FU achieving a 5-FU target AUC range (5-FU AUC0-46h between 20 and 30 mg*h/L) within two dose cycles of 5-FU, Percentage of patients undergoing FOLFIRINOX treated with 5-FU MIPD achieving a 5-FU target AUC range (5-FU AUC0-46h between 20 and 30 mg*h/L) within two dose cycles of 5-FU

Detailed description

Incidence of grade ≥ 1-5 toxicity, toxicity-related hospitalization, treatment delay (> 2 days) and early treatment withdrawal in patients treated with FOLFIRINOX, Turn-around-time of 5-FU MIPD (or incidence of treatment delay due to 5-FU MIPD), Compliance to 5-FU MIPD dosing advice by treating physicians, Pharmacokinetics of 5-FU, FUH2, Irinotecan, SN-38, SN38G and Oxaliplatin, Direct medical costs of 5-FU based treatment, Disease free surivival, progression free survival, objective response rate and overall survival of patients treated with FOLFIRINOX, AUC0-46h of 5-FU in patients treated with FOLFIRINOX, Correlation of patient and treatment characteristics with AUC of 5-FU and/or irinotecan and their metabolites

Related papers

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Interventions

DRUGIrinotecan HCl-trihydraat Fresenius Kabi 20 mg/ml

DRUGconcentraat voor oplossing voor infusie

DRUGFolikabi 10 mg/ml oplossing voor injectie/infusie

DRUGOxaliplatine Accord 5 mg/ml concentraat voor oplossing voor infusie

DRUGFluorouracil Accord 50 mg/ml

DRUGoplossing voor injectie of infusie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of patients undergoing FOLFIRINOX treated with standard-dosed (BSA) 5-FU achieving a 5-FU target AUC range (5-FU AUC0-46h between 20 and 30 mgh/L) within two dose cycles of 5-FU, Percentage of patients undergoing FOLFIRINOX treated with 5-FU MIPD achieving a 5-FU target AUC range (5-FU AUC0-46h between 20 and 30 mgh/L) within two dose cycles of 5-FU	—

Secondary

Measure	Time frame
Incidence of grade ≥ 1-5 toxicity, toxicity-related hospitalization, treatment delay (> 2 days) and early treatment withdrawal in patients treated with FOLFIRINOX, Turn-around-time of 5-FU MIPD (or incidence of treatment delay due to 5-FU MIPD), Compliance to 5-FU MIPD dosing advice by treating physicians, Pharmacokinetics of 5-FU, FUH2, Irinotecan, SN-38, SN38G and Oxaliplatin, Direct medical costs of 5-FU based treatment, Disease free surivival, progression free survival, objective response rate and overall survival of patients treated with FOLFIRINOX, AUC0-46h of 5-FU in patients treated with FOLFIRINOX, Correlation of patient and treatment characteristics with AUC of 5-FU and/or irinotecan and their metabolites	—

Measure

Time frame

Incidence of grade ≥ 1-5 toxicity, toxicity-related hospitalization, treatment delay (> 2 days) and early treatment withdrawal in patients treated with FOLFIRINOX, Turn-around-time of 5-FU MIPD (or incidence of treatment delay due to 5-FU MIPD), Compliance to 5-FU MIPD dosing advice by treating physicians, Pharmacokinetics of 5-FU, FUH2, Irinotecan, SN-38, SN38G and Oxaliplatin, Direct medical costs of 5-FU based treatment, Disease free surivival, progression free survival, objective response rate and overall survival of patients treated with FOLFIRINOX, AUC0-46h of 5-FU in patients treated with FOLFIRINOX, Correlation of patient and treatment characteristics with AUC of 5-FU and/or irinotecan and their metabolites

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Countries

Netherlands

Outcome results

None listed