WEEKLY LOW DOSE TAXOTERE IN METASTATIC MELANOMA

$0M01FY2000RRNIH

Indiana Univ-Purdue Univ At Indianapolis, Indianapolis IN

Investigators

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Abstract

This trial will assess the anti-tumor activity of low dose weekly Taxotere in patients with metastatic melanoma. Melanoma is a disease for which effective therapy does not exist for the majority of patients. Recent studies assessing the activity of standard chemotherapy agents demonstrates that the response rate for DTIC is -10% with median survials of between 4-6 months. Immunotherapy and biochemotherapy offer some patients an improved long-term outcome though these options are available only for those patients who are extremely healthy and have relatively slow-growing disease. Melanoma is a highly vascular tumor and evidence exists that angiogenesis plays a significant role in the progression of the disease. Taxotere is a novel taxane that has been shown to have modest anti-tumor activity in melanoma when administered every three weeks. Recent studies in our lab have demonstrated the TXT has anti-angiogenic activity at concentrations lower than that required for cytotoxicity. We propose to study the anti-tumor activity of lower dose weekly TXT in patients with melanoma. We will assess the PK profile of TXT as well as a series of anti-angiogenic surrogate studies to determine whether this agent has clinically meaningful anti-angiogenic activity.

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