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.

PATIENTS AND 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.

RESULTS AND CONCLUSION: 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.