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

Phase II trial of ixabepilone in patients with cisplatin-refractory germ cell tumors. Research Abstract Details 

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  • Phase II trial of ixabepilone in patients with cisplatin-refractory germ cell tumors. Abstract Text:

    darren r feldmanDarren R Feldman,g varuni kondaguntaG Varuni Kondagunta,michelle s ginsbergMichelle S Ginsberg,nicole ishillNicole Ishill,sujata patilSujata Patil,john cestaroJohn Cestaro,eugenie obbensEugenie Obbens,joel sheinfeldJoel Sheinfeld,george j boslGeorge J Bosl,robert j motzerRobert J Motzer,

    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 (>or=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.

    Phase II trial of ixabepilone in patients with cisplatin-refractory germ cell tumors. Publishing Authors By Initials

    dr feldmanDR Feldman,gv kondaguntaGV Kondagunta,ms ginsbergMS Ginsberg,n ishillN Ishill,s patilS Patil,j cestaroJ Cestaro,e obbensE Obbens,j sheinfeldJ Sheinfeld,gj boslGJ Bosl,rj motzerRJ Motzer,

    For similar neoplasms: neoplasms by histologic type: neoplasms, germ cell and embryonal research abstracts see: neoplasms: neoplasms by histologic type: neoplasms, germ cell and embryonal research

    PUBMED ID PMID:

    MEDLINE DATE:

    Phase II trial of ixabepilone in patients with cisplatin-refractory germ cell tumors. Journal Published:

    PUBLICATION TYPE: Research Support, Non-U.S. Gov

    Journal: Investigational new drugs

    VOLUME: 25

    Page Numbers: 487-90

    Journal Abbreviation:

    ISSN: 0167-6997

    DAY: 23

    MONTH: 05

    YEAR: 2007

    Phase II trial of ixabepilone in patients with cisplatin-refractory germ cell tumors. Information

    Number of References:

    LANGUAGE: eng

    NlmUniqueID: 8309330

    Phase II trial of ixabepilone in patients with cisplatin-refractory germ cell tumors. Keywords Mesh Terms:

    KEYWORDS: Neoplasms, Germ Cell and Embryonal

    MESH TERMS: drug therapy

    Chemical & Substance for Abstract: Phase II trial of ixabepilone in patients with cisplatin-refractory germ cell tumors. Information

    Substance Name: ixabepilone

    Registry Number: 219989-84-1

    Grant and Affiliation Information for Phase II trial of ixabepilone in patients with cisplatin-refractory germ cell tumors.

    AFFILIATION: Genitourinary service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA.

    Country: United States

    United States Research PublicationUnited States Research Publication

    AGENCY: United States NCI

    GRANT: CM-57732

    ACRONYM: CM

    MEDLINETA: Invest New Drugs

    REFSOURCE:

    DATABASENAME:

    ACCESSION NUMBER:

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