Abstract

Background: Preclinical studies have shown synergism between topoisomerase I and II inhibitors. Methods: We conducted a phase I study evaluating the combination of pegylated liposomal doxorubicin and irinotecan in patients with previously treated solid tumors. Results: Twelve patients were enrolled. The median age was 62 years (range 19-72). The most common grade 3/4 toxicities were neutropenia (dose-limiting toxicity), diarrhea and nausea/vomiting. The maximal tolerated dose and recommended schedule were pegylated liposomal doxorubicin 20 mg/m2 over 60 min on day 1, followed by irinotecan 100 mg/m 2 over 90 min on days 1 and 8 of a 21-day cycle. There were no objective clinical responses, but 5 patients achieved stable disease lasting a median of 11 weeks duration (range 2-35). Conclusions: This regimen should be further studied in patients with tumors known to have a sensitivity to both topoisomerase I and II inhibitors such as ovarian and small cell carcinoma.

Original languageEnglish
Pages (from-to)441-445
Number of pages5
JournalChemotherapy
Volume55
Issue number6
DOIs
StatePublished - Dec 2009

Keywords

  • Doxorubicin
  • Irinotecan
  • Phase I study

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