Investigational New Drugs

, Volume 25, Issue 1, pp 63–67 | Cite as

Phase II trial of ixabepilone, an epothilone B analog, given daily for three days every three weeks, in metastatic breast cancer

  • Neelima Denduluri
  • James J. Lee
  • Janice Walshe
  • Arlene W. Berman
  • Ujala Vatas
  • Catherine K. Chow
  • Seth M. Steinberg
  • Michael C. Cox
  • Jennifer A. Low
  • Sandra M. SwainEmail author
Phase II Studies


Twelve patients with metastatic breast cancer previously exposed to taxanes were treated on a Phase II trial with ixabepilone. Eligible patients had histologically confirmed metastatic breast cancer with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), and adequate hematopoietic, renal, and hepatic function. Ixabepilone 8 mg/m2/day was given intravenously daily for 3 days for the first 3-week cycle and increased to 10 mg/m2/day for subsequent cycles if patients did not have hematologic or other toxicity after the first cycle. Patients continued treatment until progressive disease or unacceptable toxicity. Three, 29, and 33 of 65 cycles administered were at the 7 mg/m2, 8 mg/m2 and 10 mg/m2 dose levels respectively. Grade 4 leukopenia (n=1), grade 3 neutropenia (n=2), grade 2 neuropathy (n=3), and grade 2 transaminase elevation (n=2) were the most notable toxicities. Ten patients had stable disease for at least 6 weeks. No complete or partial responses were observed in 12 evaluable patients treated with ixabepilone daily for 3 days. Although ixabepilone was well-tolerated, the dose of 8–10 mg/m2 daily for 3 days is not an effective therapy in metastatic breast cancer previously exposed to taxanes.


Docetaxel Metastatic Breast Cancer Filgrastim Pegfilgrastim Metastatic Setting 
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Copyright information

© Springer Science + Business Media, LLC 2006

Authors and Affiliations

  • Neelima Denduluri
    • 1
  • James J. Lee
    • 2
  • Janice Walshe
    • 1
  • Arlene W. Berman
    • 1
  • Ujala Vatas
    • 1
  • Catherine K. Chow
    • 3
  • Seth M. Steinberg
    • 4
  • Michael C. Cox
    • 1
  • Jennifer A. Low
    • 5
  • Sandra M. Swain
    • 1
    Email author
  1. 1.Breast Cancer Section, Medical Oncology BranchCenter for Cancer Research, National Cancer Institute, National Institutes of HeathBethesdaUSA
  2. 2.Yale Cancer CenterYale University School of MedicineNew HavenUSA
  3. 3.Diagnostic Radiology DepartmentWarrant G. Magnuson Clinical Center, National Cancer Institute, National Institutes of HealthBethesdaUSA
  4. 4.Biostatistics and Data Management Section, Office of the Clinical DirectorCenter for Cancer Research, National Cancer Institute, National Institutes of HealthBethesdaUSA
  5. 5.Cancer Therapy Evaluation Program, Division of Cancer Treatment and DiagnosisNational Cancer Institute, National Institutes of HealthBethesdaUSA

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