Phase II trial of pyrazoloacridine as second-line therapy for patients with unresectable or metastatic transitional cell carcinoma Journal Article


Authors: Dodd, P. M.; Mccaffrey, J. A.; Mazumdar, M.; Icasiano, E.; Higgins, G.; Herr, H.; Bajorin, D. F.
Article Title: Phase II trial of pyrazoloacridine as second-line therapy for patients with unresectable or metastatic transitional cell carcinoma
Abstract: 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 acitvity in patients with TCC who have failed one prior regimen.
Keywords: adult; clinical article; controlled study; aged; middle aged; clinical trial; fatigue; neutropenia; diarrhea; antineoplastic agents; chemotherapy; neurotoxicity; controlled clinical trial; phase 2 clinical trial; anemia; nausea; stomatitis; thrombocytopenia; lorazepam; urinary bladder neoplasms; fever; hyperglycemia; survival time; pyrazoles; xerostomia; headache; carcinoma, transitional cell; transitional cell carcinoma; acridines; phlebitis; 2 (2 dimethylaminoethyl) 9 methoxy 5 nitropyrazolo[3,4,5 kl]acridine; humans; human; male; female; priority journal; article
Journal Title: Investigational New Drugs
Volume: 18
Issue: 3
ISSN: 0167-6997
Publisher: Springer  
Date Published: 2000-08-01
Start Page: 247
End Page: 251
Language: English
DOI: 10.1023/a:1006477823378
PUBMED: 10958593
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 18 November 2015 -- Source: Scopus
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Citation Impact
MSK Authors
  1. Dean Bajorin
    582 Bajorin
  2. Madhu Mazumdar
    127 Mazumdar
  3. Harry W Herr
    550 Herr
  4. Geralyn A Higgins
    13 Higgins
  5. Paul M Dodd
    14 Dodd