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

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Summary

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.

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Authors and Affiliations

  1. Breast Cancer Section, Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Heath, Bldg 8, Rm 5101, 8901 Wisconsin Ave, Bethesda, MD, 20889-5015, USA

    Neelima Denduluri, Janice Walshe, Arlene W. Berman, Ujala Vatas, Michael C. Cox & Sandra M. Swain

  2. Yale Cancer Center, Yale University School of Medicine, PO Box 208028, New Haven, CT, 06520-8028, USA

    James J. Lee

  3. Diagnostic Radiology Department, Warrant G. Magnuson Clinical Center, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20889-5015, USA

    Catherine K. Chow

  4. Biostatistics and Data Management Section, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20889-5015, USA

    Seth M. Steinberg

  5. Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20889-5015, USA

    Jennifer A. Low

Authors
  1. Neelima Denduluri
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  2. James J. Lee
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  3. Janice Walshe
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  4. Arlene W. Berman
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  5. Ujala Vatas
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  6. Catherine K. Chow
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  7. Seth M. Steinberg
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  8. Michael C. Cox
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  9. Jennifer A. Low
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  10. Sandra M. Swain
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Correspondence to Sandra M. Swain.

Additional information

This work was supported by the Intramural Research Program of the Center for Cancer Research, National Cancer Institute, National Institutes of Health.

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Denduluri, N., Lee, J.J., Walshe, J. et al. Phase II trial of ixabepilone, an epothilone B analog, given daily for three days every three weeks, in metastatic breast cancer. Invest New Drugs 25, 63–67 (2007). https://doi.org/10.1007/s10637-006-9006-7

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  • DOI: https://doi.org/10.1007/s10637-006-9006-7

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