Phase I/II study of LOC-paclitaxel (LOC-Pac) in patients (pts) with metastatic melanoma.

e19039 Background: LOC-Pac is a covalent conjugate of paclitaxel (Pac) and omega-3 fatty acid. In in-vivo animal studies in various tumor models LOC-Pac was found to be superior to Pac in safety as determined by maximum tolerated dose and efficacy as determined by delay in tumor growth and complete response rates. This is the first in human phase I study of LOC-Pac. Methods: Adult patients (pts) with confirmed metastatic melanoma (MM), life expectancy > 3 months, with normal renal and liver profiles, failed prior systemic therapy (Rx) or ineligible for Rxs of higher priority, ECOG performance status 0-2 and with at least one measurable metastasis (met) were eligible to this trial. Pts with known CNS met, neuropathy > grade 1, hypersensitivity to cremophor or Paclitaxel and HIV infection, serious concurrent medical conditions were excluded. LOC-Pac was given intravenously over 1 hour on days 1, 8, 15, 22 and 29 every 42 days. Each dose of LOC-Pac was preceded by a dose of dexamethasone, diphenhydramine and...