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.
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.
Authors: S B Saxman; K J Propert; L H Einhorn; E D Crawford; I Tannock; D Raghavan; P J Loehrer; D Trump Journal: J Clin Oncol Date: 1997-07 Impact factor: 44.544
Authors: D J Vaughn; S B Malkowicz; B Zoltick; R Mick; P Ramchandani; C Holroyde; B Armstead; K Fox; A Wein Journal: J Clin Oncol Date: 1998-01 Impact factor: 44.544
Authors: D F Bajorin; J A McCaffrey; S Hilton; M Mazumdar; W K Kelly; H I Scher; J Spicer; H Herr; G Higgins Journal: J Clin Oncol Date: 1998-08 Impact factor: 44.544
Authors: J Aisner; V Weinberg; M Perloff; R Weiss; M Perry; A Korzun; S Ginsberg; J F Holland Journal: J Clin Oncol Date: 1987-10 Impact factor: 44.544
Authors: B J Roth; R Dreicer; L H Einhorn; D Neuberg; D H Johnson; J L Smith; G R Hudes; S M Schultz; P J Loehrer Journal: J Clin Oncol Date: 1994-11 Impact factor: 44.544
Authors: Bhuvaneswari Ramaswamy; Ewa Mrozek; John Philip Kuebler; Tanios Bekaii-Saab; Eric H Kraut Journal: Invest New Drugs Date: 2009-10-21 Impact factor: 3.850