A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma
Data Collection
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.103 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 28 locations
Univ Of Arkansas/Arkansas Research Center
Little Rock, United StatesScripps Cancer Center
San Diego, United StatesNorthern California Melanoma Center
San Francisco, United States