STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma

This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients.

STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.

Inclusion Criteria:

• M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
• ECOG performance status of greater than or equal to 2
• Measurable disease per RECIST criteria
• Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed)
• At least 4 weeks have passed since last chemotherapy or immunotherapy
• At least 2 weeks have passed since last radiotherapy.
• Life expectancy of greater than 12 weeks
• Clinical lab values within protocol parameters

Exclusion Criteria:

• Female patients pregnant or lactating
• Female patients of childbearing potential not using or not willing to use effective contraception
• Presence of a second malignancy other than nonmelanoma skin cancer
• Presence of a clinically significant and uncontrolled infection
• Presence of clinically significant arrythmias
• Presence of serious concurrent illness or other conditions that do not permit adequate follow-up and compliance with protocol
• History of severe hypersensitivity reactions to taxanes
• Use of any investigational agents within 4 weeks prior to the first dose of study drug