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Phase I trial of ixabepilone plus pegylated liposomal doxorubicin in patients with adenocarcinoma of breast or ovary†‡

  1. E. Chuang1,*,
  2. N. Wiener1,
  3. P. Christos2,
  4. R. Kessler1,
  5. M. Cobham1,
  6. D. Donovan1,
  7. G. L. Goldberg3,
  8. T. Caputo4,
  9. A. Doyle5,
  10. L. Vahdat1 and
  11. J. A. Sparano6
  1. 1Department of Medicine
  2. 2Division of Biostatistics and Epidemiology, Department of Public Health, Weill Cornell Medical College, New York, NY
  3. 3Department of Obstetrics and Gynecology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY
  4. 4Department of Obstetrics and Gynecology, Weill Cornell Medical College, New York, NY
  5. 5Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD
  6. 6Department of Medicine and Gynecology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA
  1. *Correspondence to: Dr E. Chuang, Department of Medicine, Weill Cornell Medical College, 425 E. 61st Street, New York, NY 10065, USA. Tel: +1 212-821-0654; Fax: +1 212-821-0796; E-mail: elc2007{at}med.cornell.edu
  • Received December 23, 2009.
  • Revision received February 15, 2010.
  • Accepted February 18, 2010.

Abstract

Background: Ixabepilone is a semisynthetic epothilone B analogue that is active in taxane-resistant cell lines and has shown activity in patients with refractory breast and ovarian cancer. We carried out a phase I trial of ixabepilone plus pegylated liposomal doxorubicin (PLD) in patients with advanced taxane-pretreated ovarian and breast cancer.

Methods: Patients with recurrent ovarian or breast carcinoma received PLD every 3 or 4 weeks plus five different dose schemas of ixabepilone in cohorts of three to six patients.

Results: Thirty patients received a total of 142 treatment cycles of the PLD–ixabepilone combination. The recommended phase II dose and schedule of ixabepilone was 16 mg/m2 on days 1, 8, and 15 plus PLD 30 mg/m2 given on day 1, repeated every 4 weeks. Hand–foot syndrome and mucositis were dose limiting when both ixabepilone and PLD were given every 3 or 4 weeks. Objective responses were observed in 3 of 13 patients (23%) with breast cancer and 5 of 17 patients (29%) with ovarian cancer.

Conclusion: Ixabepilone may be safely combined with PLD, but tolerability is highly dependent upon the scheduling of both agents. This combination demonstrated efficacy in patients with breast and ovarian cancer and merits further evaluation in these settings.

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    1. Ann Oncol (2010) doi: 10.1093/annonc/mdq080 First published online: March 31, 2010
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