Assessment of Pharmacokinetic Interaction Between Capecitabine and Cetuximab in Metastatic Colorectal Cancer Patients

This study focuses on the plasma disposition and metabolic activation of capecitabine (CCB) when administered alone or when combined with cetuximab (CTX). Twenty-four chemo-naïve patients with KRAS wild-type colorectal cancer were randomized into two arms and received either CCB alone (1,000 mg/m(2)...

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Bibliographic Details
Published in:Anticancer research 2016-09, Vol.36 (9), p.4715-4724
Main Authors: Rachar, Veronika, Czejka, Martin, Kitzmueller, Marie, Buchner, Philipp, Lichtneckert, Maria, Greil, Richard, Geiler, Herbert, Dittrich, Christian
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Capecitabine - administration & dosage
Capecitabine - adverse effects
Capecitabine - blood
Capecitabine - pharmacokinetics
Cetuximab - administration & dosage
Cetuximab - adverse effects
Cetuximab - blood
Colorectal Neoplasms - blood
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - pathology
Drug Interactions
Female
Humans
Male
Middle Aged
Neoplasm Metastasis
Proto-Oncogene Proteins p21(ras) - genetics
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Summary:This study focuses on the plasma disposition and metabolic activation of capecitabine (CCB) when administered alone or when combined with cetuximab (CTX). Twenty-four chemo-naïve patients with KRAS wild-type colorectal cancer were randomized into two arms and received either CCB alone (1,000 mg/m(2) bid p.o.), followed by CCB plus CTX (loading dose (LD)=400 mg/m(2) followed by 250 mg/m(2) weekly i.v. maintenance dose) (Arm A; n=12 patients (patients)) or CCB plus CTX followed by CCB alone (Arm B; n=12 patients). Plasma samples were collected from the cubital vein and CCB, 5'-desoxy-5-fluorocytidine (5'-DFCR) and 5'-desoxy-5 fluorouridine (5'-DFUR) were quantified by a sensitive, selective reversed phase high-performance liquid chromatography (HPLC) assay. Non-compartment pharmacokinetic parameters have been calculated by Phoenix WinNonlin. No clinically relevant impact of CTX on CCB pharmacokinetic parameters and metabolic conversion could be detected in both arms after statistical evaluation (ANOVA). From the pharmacokinetic point of view, co-administration of CTX to CCB seems to be safe.
ISSN:0250-7005
1791-7530
DOI:10.21873/anticanres.11026