Phase II Trial of ixabepilone in patients with cisplatin-refractory germ cell tumors Journal Article
| Authors: | Feldman, D. R.; Kondagunta, G. V.; Ginsberg, M. S.; Ishill, N.; Patil, S.; Cestaro, J.; Obbens, E.; Sheinfeld, J.; Bosl, G. J.; Motzer, R. J. |
| Article Title: | Phase II Trial of ixabepilone in patients with cisplatin-refractory germ cell tumors |
| Abstract: | 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. © 2007 Springer Science+Business Media, LLC. |
| Keywords: | adult; clinical article; human tissue; middle aged; clinical trial; neutropenia; cisplatin; drug dose reduction; hypophosphatemia; antineoplastic agents; cancer patient; multiple cycle treatment; phase 2 clinical trial; anemia; tumor volume; leukopenia; neuropathy; stomatitis; thrombocytopenia; antineoplastic activity; drug resistance, neoplasm; tumor marker; febrile neutropenia; hyperglycemia; lymphocytopenia; hypokalemia; hyponatremia; hypoglycemia; radiography; neoplasms, germ cell and embryonal; taxane derivative; germ cell tumor; germ cell tumors; nomogram; ixabepilone; epothilones; institutional care; pharyngitis; bms-247550 |
| Journal Title: | Investigational New Drugs |
| Volume: | 25 |
| Issue: | 5 |
| ISSN: | 0167-6997 |
| Publisher: | Springer |
| Date Published: | 2007-10-01 |
| Start Page: | 487 |
| End Page: | 490 |
| Language: | English |
| DOI: | 10.1007/s10637-007-9059-2 |
| PUBMED: | 17520176 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 12" - "Export Date: 17 November 2011" - "CODEN: INNDD" - "Source: Scopus" |
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