[A phase I study of carboplatin]

A phase I study of carboplatin was conducted using a single dose schedule. Escalating doses of 200, 300, 400 and 500mg/m2 were administered without hydration up to a total of 21 cycles in 18 patients with various solid tumors. A dose-limiting factor was thrombocytopenia, and leukopenia was also dose-related. A major clinical toxicity was gastrointestinal toxicity, while nephrotoxicity was extremely mild. The optimal dose for phase II trials was judged to be 300mg/m2 q 4w in poor-risk patients and 400mg/m2 q 4w in good-risk patients, respectively. Pharmacokinetics were studied in 11 patients.