Liposomal cisplatin dose escalation for determining the maximum tolerated dose and dose-limiting toxicity: a phase I study.
BACKGROUND
The aim of the present trial was to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of liposomal cisplatin (lipoplatin) using nephrotoxicity, gastrointestinal toxicity and myelotoxicity as the main adverse reactions.


METHODS
Lipoplatin, a liposomal formulation of cisplatin was first tested as monotherapy starting at a dose of 125 mg/m(2) and escalating up to 350 mg/m(2). Lipoplatin was then escalated in combination with paclitacel starting at a dose of 100 mg/m(2) escalating up to 250 mg/m(2) for the former and 100 mg/m(2) escalating up to 175 mg/m(2) for the latter.


CONCLUSIONS
The present trial determined the DLT for lipoplatin monotherapy at 350 mg/m(2) and the MTD at 300 mg/m(2); for lipoplatin-paclitaxel combination therapy, the DLT was 250 mg/m(2) for lipoplatin and 175 mg/m(2) for paclitaxel whereas the MTD was 200 mg/m(2) for lipoplatin and 175 mg/m(2) for paclitaxel.
First Oncology Clinic, Errikos Dunant Hospital, Athens, Greece. dr-gps@ath.forthnet.gr
G P
GP
Stathopoulos
S K
SK
Rigatos
J
J
Stathopoulos
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects*; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects
D000970:Antineoplastic Agents; C503131:lipoplatin; D017239:Paclitaxel; D002945:Cisplatin