Prolonged intermittent oral topotecan in patients with refractory and/or advanced malignancies

摘要: To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dosage of oral topotecan when administered in an intermittent schedule. Phase I study. Patients received a fixed dose daily for 5 7 days 2 or 3 consecutive weeks followed by 1 week rest (21- 28-day cycles, respectively). were accrued at seven different levels ranging from 1.25 to 3.0 mg/day. Fifty-five patients total 153 cycles therapy. Dose-limiting toxicities consisted neutropenia, thrombocytopenia, diarrhea appeared correlate with patient characteristics associated low clearance, such as impaired renal function, bodyweight, decreased performance status. Three partial responses reported lung cancer (non-small cell two small one patient). The further testing is 2.0 mg/day function (calculated creatinine clearance ≤70 mL/min) 2.5 normal >70 mL/min). Treatment should be repeated every 21 days.