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Phase II Trial of Pyrazoloacridine as Second-Line Therapy for Patients with Unresectable or Metastatic Transitional Cell Carcinoma

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Abstract

Purpose: A phase II trial of pyrazoloacridine(PZA) was conducted to assess its activity andtoxicity in patients with advanced transitional cellcarcinoma (TCC) refractory to or progressing after oneprior cisplatin-, carboplatin- or paclitaxel- basedregimen.

Patients and methods: PZA at a dose of750 mg/m2 was administered to 14 patients as athree-hour intravenous infusion on day 1 every 21days. Premedication consisted of lorazepam 0.5-1.0 mgprior to each cycle to alleviate central nervoussystem toxicity. Reduction of subsequent doses wasmade for hematologic or central nervous systemtoxicity.

Results: Among fourteen patients evaluable forresponse, no responses were observed (0% responserate; 95% confidence interval 0% to 23%). Themedian duration of survival for all patients was 9months with a median follow-up of 8.5 months. Toxicityto 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 nothave significant single-agent acitvity in patientswith TCC who have failed one prior regimen.

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Authors and Affiliations

  1. The Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine; the Division of Urology, Department of Surgery; the Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY

    Paul M. Dodd, John A. McCaffrey, Madhu Mazumdar, Evelyn Icasiano, Geralyn Higgins, Harry Herr & Dean F. Bajorin

  2. Department of Medicine, Weill Medical College of Cornell University, New York, NY, USA

    Paul M. Dodd, John A. McCaffrey, Madhu Mazumdar, Evelyn Icasiano, Geralyn Higgins, Harry Herr & Dean F. Bajorin

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  1. Paul M. Dodd
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  2. John A. McCaffrey
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  4. Evelyn Icasiano
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  6. Harry Herr
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  7. Dean F. Bajorin
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Dodd, P.M., McCaffrey, J.A., Mazumdar, M. et al. Phase II Trial of Pyrazoloacridine as Second-Line Therapy for Patients with Unresectable or Metastatic Transitional Cell Carcinoma. Invest New Drugs 18, 247–251 (2000). https://doi.org/10.1023/A:1006477823378

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  • DOI: https://doi.org/10.1023/A:1006477823378

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