Phase-I Study of Protracted Infusion of Cisplatin

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Abstract
A continuous infusion schedule for cisplatin employing a portable infusion pump was studied in a phase-I trial designed to establish an optimal daily dose rate to deliver drug for protracted periods (up to 30 days) [to metastatic malignancy patients]. Fifteen trials were carried out in 14 patients at daily dose rates of 5, 6.5, 7.5 and 10.0 mg/m2 .cntdot. day. The median duration of therapy at the respective doses was 21, 17, 8 and 7 days. Dose-limiting toxicity was recalcitrant and protracted nausea was observed in all patients receiving 5 mg/m2 .cntdot. day. One patient did develop mild thrombocytopenia (98,000) at day 35. Renal failure was relatively minor considering the absence of a concomitantly delivered hydration regimen but 3 patients did develop a transient rise in serum creatinine, 2 of whom had a solitary kidney or partial urinary tract obstruction. No patient developed renal failure at 5 mg/m2 .cntdot. day. At the recommended dose of 5 mg/m2 .cntdot. day, the cumulative dose of cisplatin delivered by a protracted infusion schedule is comparable to the intermittent high-dose regimen with less adverse drug complications.