Evaluation of pharmacokinetics and safety of cetuximab with cisplatin/carboplatin in patients with advanced solid tumor: Result from phase II studies

AbstractThe pharmacokinetics and potential drug –drug interactions between cetuximab and cisplatin or carboplatin from two studies (JXBA and JXBB) were evaluated. These studies were multicenter, open‐label phase II trials designed to evaluate the drug–drug interactions between cetuximab (400 mg m−2 initial dose) and cisplatin (JXBA;  100 mg m−2) or carboplatin (JXBB;  area under the curve [AUC] = 5 mg × min mL−1) with or without 5 ‐fluorouracil (5FU) in patients with advanced solid tumors. Concentrations of cetuximab, cisplatin and carboplatin were determined using analytical methods. The safety and tolerability of cetuximab in combination with cisplatin or carboplatin was also determined in all treated patients. The JXBA s tudy showed that cetuximab serum concentrations were similar when cetuximab was administered alone or in combination with cisplatin. TheCmax,tmax and overall AUC for the cetuximab group (194  µg mL−1, 2.0  hour, 14 900 µg × h mL−1) and the cetuximab and cisplatin combination group (192  µg mL−1, 1.99  hour, 16 300 µg × h mL−1) were similar. The JXBB study showed that mean cetuximab serum concentrations were similar when cetuximab was administered alone or in combination with carboplatin. TheCmax,tmax and overall AUC for the cetuximab group (199  µg mL−1, 1.15  hour, 17 200 µg × h mL−1) and the cetuximab and carboplatin combination group (199  µg mL−1, 3.17  h, 16 800 µg ×...
Source: Pharmacology Research and Perspectives - Category: Drugs & Pharmacology Authors: Tags: ORIGINAL ARTICLE Source Type: research