Phase II trial of weekly ixabepilone in men with metastatic castrate-resistant prostate cancer (E3803): A trial of the Eastern cooperative oncology group

Glenn Liu, Yu Hui Chen, Robert Dipaola, Michael Carducci, George Wilding

Research output: Contribution to journalArticlepeer-review

18 Scopus citations


Purpose: BMS-247550 (ixabepilone) is an epothilone B analogue with activity in taxane-resistant cancer cell lines. Here we report the activity and toxicity of ixabepilone, administered by using a weekly schedule, in men with metastatic castrate-resistant prostate cancer (CRPC). Experimental Design: Patients with metastatic CRPC received ixabepilone at 20 mg/m 2 intravenous weekly x 3, in 4-week cycles. This noncomparative study stratified patients to either a chemotherapy naive (CN), prior taxane (Tax) only, or 2 prior cytotoxic (TCx) chemotherapy arm. The primary endpoint was prostate-specific antigen response by using PCWG (Prostate Cancer Working Group) 1 criteria. Secondary endpoints included radiographic response when using RECIST (Response Evaluation Criteria In Solid Tumors). Results: In total, 124 patients were enrolled, of whom, 109 were eligible (35 CN, 42 Tax, and 32 TCx) for the primary response determination in this study. Prostate-specific antigen responses were seen in 12 (34.3%) of 35, 12 (28.6%) of 42, and 7 (21.9%) of 32 patients with the partial objective response in 5 (22.7%) of 22, 2 (8.0%) of 25, and 0 (0.0%) of 24 patients for the CN, Tax, and TCx arms, respectively. Significant (grade 3/4) neutropenia was seen in 6 (15.4%), 7 (14.6%), and 9 (25.0%); and grade 3/4 sensory neuropathy was seen in 8 (20.5%), 12 (25.0%), and 12 (33.3%) for CN, Tax, and TCx, respectively. Grade 3/4 thrombocytopenia was infrequent and seen in only one patient on the CN and the TCx arm. Conclusion: Ixabepilone was found to have an acceptable toxicity profile when administered by using a weekly schedule with less myelosuppression compared with prior studies when using the every 3-week schedule. Single-agent activity was observed and met prespecified activity levels for the Tax treated arm.

Original languageEnglish
Pages (from-to)99-105
Number of pages7
JournalClinical Genitourinary Cancer
Issue number2
StatePublished - Jun 2012

Bibliographical note

Funding Information:
Sources of support: This study was conducted by the ECOG (Robert L. Comus, MD) and supported in part by Public Health Service grants CA23318 , CA66636 , CA21115 , CA21076 , CA107868 , CA16116 , CA80775 and from the National Cancer Institute , National Institutes of Health , and the Department of Health and Human Services . Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.


  • 2/20/2011
  • BMS-247550
  • Chemotherapy
  • Epothilone
  • Microtubule-inhibitor
  • NCT00087139
  • Version date

ASJC Scopus subject areas

  • Oncology
  • Urology


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