A phase II trial of the epothilone B analog ixabepilone (BMS-247550) in patients with metastatic melanoma.

PloS One
Patrick A OttAnna C Pavlick

Abstract

Ixabepilone (BMS-247550), an epothilone B analog, is a microtubule stabilizing agent which has shown activity in several different tumor types and preclinical models in melanoma. In an open label, one-arm, multi-center phase II trial the efficacy and toxicity of this epothilone was investigated in two different cohorts: chemotherapy-naïve (previously untreated) and previously treated patients with metastatic melanoma. Eligible patients had histologically-confirmed stage IV melanoma, with an ECOG performance status of 0 to 2. Ixabepilone was administered at a dose of 20 mg/m(2) on days 1, 8, and 15 during each 28-day cycle. The primary endpoint was response rate (RR); secondary endpoints were time to progression (TTP) and toxicity. Twenty-four patients were enrolled and 23 were evaluable for response. Initial serum lactate dehydrogenase (LDH) levels were elevated in 6/11 (55%) of the previously treated and in 5/13 (38%) of the previously untreated patients. No complete or partial responses were seen in either cohort. One patient in the previously treated group developed neutropenia and fatal septic shock. Seventeen patients (8 in the previously untreated group and 9 in the previously treated group) progressed after 2 cycles, whe...Continue Reading

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Citations

May 4, 2012·Archives of Pharmacal Research·Do-Hee Kim, Taebo Sim
Jan 25, 2012·Oncology·Nagashree SeetharamuAnna C Pavlick
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Oct 12, 2010·Cancer Biology & Therapy·Tetyana V BagnyukovaIgor Astsaturov

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Methods Mentioned

BETA
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NCT00036764

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