A phase i study of pegylated liposomal doxorubicin and irinotecan in patients with solid tumors

Daniel Morgensztern, Maria Q. Baggstrom, Giancarlo Pillot, Benjamin Tan, Paula Fracasso, Rama Suresh, Jonathan Wildi, Ramaswamy Govindan

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

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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