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Phase II trial of pyrazoloacridine as second-line therapy for patients with unresectable or metastatic transitional
P M Dodd1, J A McCaffrey, M Mazumdar
1Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
Purpose:
A phase II trial of pyrazoloacridine (PZA) was conducted to assess its activity and toxicity in patients with advanced transitional cell carcinoma (TCC) refractory to or progressing after one prior cisplatin-, carboplatin- or paclitaxel- based regimen.
Patients And Methods:
PZA at a dose of 750 mg/m2 was administered to 14 patients as a three-hour intravenous infusion on day 1 every 21 days. Premedication consisted of lorazepam 0.5-1.0 mg prior to each cycle to alleviate central nervous system toxicity. Reduction of subsequent doses was made for hematologic or central nervous system toxicity.
Results:
Among fourteen patients evaluable for response, no responses were observed (0% response rate; 95% confidence interval 0% to 23%). The median duration of survival for all patients was 9 months with a median follow-up of 8.5 months. Toxicity to PZA included grade 3 or 4 neutropenia in 8/14 (57%) and grade 3 or 4 thrombocytopenia in 2/14 (14%). Non-hematologic toxicity was mild.
Conclusions:
PZA at this dose and schedule does not have significant single-agent activity in patients with TCC who have failed one prior regimen.