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 Journal Article


Authors: Bajorin, D. F.; Mccaffrey, J. A.; Dodd, P. M.; Hilton, S.; Mazumdar, M.; Kelly, W. K.; Herr, H.; Scher, H. I.; Icasiano, E.; Higgins, G.
Article Title: 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
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.
Keywords: adult; cancer survival; clinical article; aged; aged, 80 and over; disease-free survival; middle aged; clinical trial; cisplatin; advanced cancer; cancer combination chemotherapy; dose response; paclitaxel; chemotherapy; neurotoxicity; metastasis; phase 2 clinical trial; cohort studies; blood toxicity; antineoplastic combined chemotherapy protocols; kidney failure; urogenital tract cancer; ifosfamide; time factors; febrile neutropenia; urologic neoplasms; feasibility studies; taxoids; inoperable cancer; mesna; recombinant granulocyte colony stimulating factor; carcinoma, transitional cell; alopecia; transitional cell carcinoma; humans; prognosis; human; male; female; priority journal; article; urothelial tract
Journal Title: Cancer
Volume: 88
Issue: 7
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2000-04-01
Start Page: 1671
End Page: 1678
Language: English
DOI: 10.1002/(sici)1097-0142(20000401)88:7<1671::aid-cncr22>3.0.co;2-a
PUBMED: 10738226
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. William K Kelly
    115 Kelly
  3. Madhu Mazumdar
    127 Mazumdar
  4. Susan Hilton
    28 Hilton
  5. Harry W Herr
    550 Herr
  6. Howard Scher
    1058 Scher
  7. Geralyn A Higgins
    13 Higgins
  8. Paul M Dodd
    14 Dodd