A phase II study of ixabepilone (BMS-247550) in metastatic renal-cell carcinoma

Edwin M. Posadas*, Samir Undevia, Elizabeth Manchen, James L. Wade, A. Dimitrios Colevas, Theodore Karrison, Everett E. Vokes, Walter M. Stadler

*Corresponding author for this work

Research output: Contribution to journalArticle

22 Scopus citations

Abstract

Introduction: Ixabepilone (BMS-247550) is a semi-synthetic analog of epothilone B that has been characterized as a microtubule stabilizing agent with a mechanism of action distinct from taxanes. Suggestion of activity in renal cell carcinoma (RCC) has been seen in early clinical studies. Methods: Eligible patients had metastatic RCC as well as ECOG performance status 0-2 and normal organ function. Patients received ixabepilone at a dose of 40 mg/m2 intravenously over three hours every 21 days. There was no restriction on RCC histology or prior treatment type, but prior treatment with tubule inhibitors was not allowed. The primary endpoint was RECIST defined response and radiographic evaluations were performed every three cycles. Toxicity evaluations utilized CTCAE v3.0 and were performed every cycle. Using a Simon two-stage optimal design with α = 0.1, β = 0.1, a null hypothesized response rate of 0.05 and an alternative response rate of 0.2, an initial 12 patients were to be accrued with full accrual of 37 patients if at least one response were observed. Results: A median of five cycles were administered. No objective responses were observed in the first 12 evaluable patients, and six patients showed stable disease for more than 18 weeks on therapy. Median time to progression among those with objective progression was nine weeks. One patient experienced grade 4 anemia and lymphopenia. Grade 3 adverse events included lymphopenia, neutropenia, leukopenia, diarrhea, and infection. Common grade 2 toxicities included alopecia, fatigue and anemia. Conclusion: Ixabepilone administered at a dose of 40 mg/m2 every 21 days should not be advanced for further study in metastatic RCC. Given previous results, however, other dosing schedules may be worthy of further investigation.

Original languageEnglish (US)
Pages (from-to)490-493
Number of pages4
JournalCancer Biology and Therapy
Volume6
Issue number4
DOIs
StatePublished - Apr 2007

Keywords

  • Chemotherapy
  • Clinical trial
  • Ixabepilone
  • Microtubule inhibitor
  • Renal cell carcinoma

ASJC Scopus subject areas

  • Molecular Medicine
  • Oncology
  • Pharmacology
  • Cancer Research

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    Posadas, E. M., Undevia, S., Manchen, E., Wade, J. L., Colevas, A. D., Karrison, T., Vokes, E. E., & Stadler, W. M. (2007). A phase II study of ixabepilone (BMS-247550) in metastatic renal-cell carcinoma. Cancer Biology and Therapy, 6(4), 490-493. https://doi.org/10.4161/cbt.6.4.3831