Ifosfamide, paclitaxel, and cisplatin for patients with advanced transitional cell carcinoma of the urothelial tract: Final report of a phase II trial evaluating two dosing schedules

Dean F. Bajorin, John A. McCaffrey, Paul M. Dodd, Susan Hilton, Madhu Mazumdar, W. Kevin Kelly, Harry Herr, Howard I. Scher, Evelyn Icasiano, Geralyn Higgins

Research output: Contribution to journalArticlepeer-review

111 Scopus citations

Abstract

BACKGROUND. A combination regimen of ifosfamide, paclitaxel, and cisplatin (ITP), recycled every 4 weeks, was reported in the treatment of previously untreated patients with advanced transitional cell carcinoma (TCC). This study sought to examine ITP at 3-week intervals to assess its feasibility and toxicity, compare the results for different schedules, and assess the impact of prognostic factors and postchemotherapy surgery on outcome. METHODS. ITP (ifosfamide 1.5 g/m2 daily for 3 days, paclitaxel 200 mg/m2 over 3 hours, and cisplatin 70 mg/m2 on Day 1) was administered to patients with metastatic or unresectable TCC and was recycled every 4 weeks (for 30 patients) or 3 weeks (for 15 patients). Granulocyte-colony stimulating factor was given during each cycle. RESULTS. Thirty of 44 assessable patients (68%; 95% confidence interval, 52-81%) demonstrated a major response (10 complete responses [23%], 20 partial [45%]), with durations of response ranging from 4 to 36 months. At a median follow-up of 28 months, the median survival was 20 months. Eleven patients (25%) were disease free at last follow-up. Overall toxicity for the 15 patients whose treatment was recycled at 3 weeks was similar to that for patients treated every 4 weeks. Hematologic toxicity included anemia, thrombocytopenia, and febrile neutropenia. Febrile neutropenia was observed in 7 patients (16%) and in 3.3% of cycles of therapy. No Grade 4 nonhematologic toxicity was observed Grade 3 nonhematologic toxicity included alopecia, renal insufficiency (11%), and neuropathy (9%). CONCLUSIONS. ITP is an active, well-tolerated regimen for previously untreated patients with TCC of the urothelial tract, resulting in a median survival of 20 months. Treatment can be recycled at 3-week intervals without enhanced toxicity. (C) 2000 American Cancer Society.

Original languageEnglish
Pages (from-to)1671-1678
Number of pages8
JournalCancer
Volume88
Issue number7
DOIs
StatePublished - 1 Apr 2000

Keywords

  • Chemotherapy
  • Cisplatin
  • Ifosfamide
  • Paclitaxel
  • Transitional cell carcinoma
  • Urothelial tract

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