Investigational New Drugs

, Volume 25, Issue 5, pp 487–490

Phase II Trial of ixabepilone in patients with cisplatin-refractory germ cell tumors

  • Darren R. Feldman
  • G. Varuni Kondagunta
  • Michelle S. Ginsberg
  • Nicole Ishill
  • Sujata Patil
  • John Cestaro
  • Eugenie Obbens
  • Joel Sheinfeld
  • George J. Bosl
  • Robert J. Motzer
PHASE II STUDIES

DOI: 10.1007/s10637-007-9059-2

Cite this article as:
Feldman, D.R., Kondagunta, G.V., Ginsberg, M.S. et al. Invest New Drugs (2007) 25: 487. doi:10.1007/s10637-007-9059-2

Summary

In a phase I study, ixabepilone, a novel non-taxane microtubule-stabilizing agent, demonstrated activity against both paclitaxel-sensitive and paclitaxel-refractory solid tumors. We conducted a phase II trial of this agent in patients with advanced germ cell tumors (GCT) who were resistant to conventional therapies.

Patients with cisplatin-refractory GCT were enrolled in this single-institution, phase II trial. Ixabepilone was administered at a dose of 40 mg/m2 intravenously over 3 hours every 21 days. Dose modifications were planned according to a nomogram for adverse events. Responses were assessed every 6 weeks using tumor markers and radiographic imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST). Patients who progressed (≥20% increase in tumor size or rising serum tumor markers) were taken off protocol.

Twenty-nine cycles of treatment were administered to 12 patients. The most common Grade 3/4 toxicities were leukopenia, lymphopenia, and neutropenia. One patient (8%) achieved a confirmed objective partial response but this patient had not received prior treatment with a taxane. Based on slow accrual and a lack of antitumor activity in patients previously treated with a taxane, the trial was closed after enrolling 12 patients.

For patients who had previously received taxane therapy, ixabepilone was not efficacious in the treatment of cisplatin-refractory GCT.

Keywords

Ixabepilone Germ cell tumors Clinical trial BMS-247550 

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Darren R. Feldman
    • 1
  • G. Varuni Kondagunta
    • 1
  • Michelle S. Ginsberg
    • 2
  • Nicole Ishill
    • 4
  • Sujata Patil
    • 4
  • John Cestaro
    • 1
  • Eugenie Obbens
    • 5
  • Joel Sheinfeld
    • 3
  • George J. Bosl
    • 1
  • Robert J. Motzer
    • 1
  1. 1.Genitourinary service, Department of MedicineMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  2. 2.Department of RadiologyMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  3. 3.Department of UrologyMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  4. 4.Department of Biostatistics, Epidemiology and StatisticsMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  5. 5.Department of NeurologyMemorial Sloan-Kettering Cancer CenterNew YorkUSA

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