Phase I study of high-dose piroxantrone with granulocyte colony-stimulating factor

Diane M.F. Savarese, Andrea M. Denicoff, Stacey L. Berg, Marianne Hillig, Stephen P. Baker, Joyce A. O'Shaughnessy, Catherine Chow, Gregory A. Otterson, Frank M. Balis, David G. Poplack, Kenneth H. Cowan

Research output: Contribution to journalArticlepeer-review

11 Scopus citations


Purpose: We performed a phase I trial of piroxantrone with and without granulocyte colony-stimulating factor (G-CSF) to determine whether the use of this cytokine would enable us to increase the dose-intensity of piroxantrone. Patients and Methods: Thirty-eight patients received 121 courses of piroxantrone administered once every 21 days. Initial patient cohorts received piroxantrone alone starting at 150 mg/m2 and the dose was escalated in subsequent patients until dose-limiting toxicity (DLT) was reached. Patient cohorts then received escalating doses of piroxantrone starting at 185 mg/m2 administered with G-CSF beginning day 2. Results: Dose-limiting neutropenia occurred in three of six patients treated with 185 mg/m2 piroxantrone; the maximum-tolerated dose (MTD) of piroxantrone alone was 150 mg/m2. Three of six patients treated with piroxantrone and G-CSF exhibited dose-limiting thrombocytopenia at 445 mg/m2; the MTD of piroxantrone with G-CSF was thus 355 mg/m2. Seven patients developed symptomatic congestive heart failure (CHF) at cumulative piroxantrone doses ranging from 855 to 2,475 mg/m2 and two have died of cardiotoxicity. Of these patients, six of seven had previously received doxorubicin. Other nonhematologic toxicity was mild. Conclusion: The use of G-CSF results in a more than twofold increase in the MTD of piroxantrone. However, symptomatic cardiotoxicity is prominent, especially in patients who have received prior treatment with anthracyclines.

Original languageEnglish (US)
Pages (from-to)1795-1803
Number of pages9
JournalJournal of Clinical Oncology
Issue number9
StatePublished - 1993
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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