Abstract
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 of oral topotecan daily for 5 of 7 days for 2 or 3 consecutive weeks followed by 1 week of rest (21- or 28-day cycles, respectively). Patients were accrued at seven different dosage levels of topotecan ranging from 1.25 to 3.0 mg/day. Fifty-five patients received a total of 153 cycles of therapy. Dose-limiting toxicities consisted of neutropenia, thrombocytopenia, and diarrhea and appeared to correlate with patient characteristics associated with low topotecan clearance, such as impaired renal function, low bodyweight, and decreased performance status. Three partial responses were reported in patients with lung cancer (non-small cell in two patients and small cell in one patient). The recommended dosage for further phase II testing is 2.0 mg/day for 5 of 7 days for 2 weeks in patients with impaired renal function (calculated creatinine clearance ≤70 mL/min) and 2.5 mg/day for 5 of 7 days for 2 weeks in patients with normal renal function (calculated creatinine clearance >70 mL/min). Treatment cycles should be repeated every 21 days.
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call