Cisplatin, gemcitabine, and ifosfamide as weekly therapy: A feasibility and phase II study of salvage treatment for advanced transitional-cell carcinoma

Lance C. Pagliaro, Randall E. Millikan, Shi Ming Tu, Dallas Williams, Danai Daliani, Christos N. Papandreou, Christopher J. Logothetis

Research output: Contribution to journalArticle

59 Scopus citations

Abstract

Purpose: We investigated the feasibility, safety, and antitumor activity of weekly gemcitabine given in combination with low doses of cisplatin and ifosfamide in previously treated patients with advanced transitional-cell carcinoma (TCC) of the urothelium. Patients and Methods: Patients with measurable, metastatic or unresectable TCC who had received one or two prior chemotherapy regimens were eligible. On a 28-day course, doses of cisplatin 30 mg/m2, gemcitabine 800 mg/m2, and ifosfamide 1 g/m2 were given on day 1 and then repeated on day 8 and day 15 unless there was dose-limiting hematologic toxicity. Results: Fifty-one patients were registered; 10 patients participated in a pilot study, after which 41 patients were registered onto the phase II protocol. Forty-eight patients (94.1%) had dose-limiting hematologic toxicity on day 8 or day 15. Nonhematologic toxicity of grade 3 or greater consisted mainly of nausea and vomiting (seven patients, 13.7%) and infection (seven patients, 13.7%). Responses could be assessed in 49 of 51 eligible patients; two complete responses (4.1%) and 18 partial responses (36.7%) were observed for an overall response rate of 40.8% (exact 95% confidence interval, 27% to 56%). Conclusion: This regimen of cisplatin, gemcitabine, and ifosfamide is not feasible for weekly administration because of hematologic toxicity. Nevertheless, there was promising activity with only two doses per 28-day cycle. On the basis of these results, we have initiated a phase II trial of this combination given as a single dose every 14 days in patients with untreated, metastatic urothelial carcinoma.

Original languageEnglish (US)
Pages (from-to)2965-2970
Number of pages6
JournalJournal of Clinical Oncology
Volume20
Issue number13
DOIs
StatePublished - Jul 1 2002

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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