Phase II Trial of ixabepilone in patients with cisplatin-refractory germ cell tumors
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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.
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Investigational New Drugs
Volume 25, Issue 5 , pp 487-490
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- Springer US
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- Germ cell tumors
- Clinical trial
- Industry Sectors
- Author Affiliations
- 1. Genitourinary service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, 10021, USA
- 2. Department of Radiology, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, 10021, USA
- 4. Department of Biostatistics, Epidemiology and Statistics, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, 10021, USA
- 5. Department of Neurology, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, 10021, USA
- 3. Department of Urology, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, 10021, USA