Expired Study
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Durham, North Carolina 27703


Purpose:

This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.


Criteria:

Inclusion Criteria: - Confirmed Metastatic Melanoma - At least 18 years old - No other active malignancy - Hemoglobin at least 9 - Platelet Count at least 100,000 cells/mm3 - ANC at least 1500 cells/mm3 - AST & ALT less than 2.5X upper limit of normal - Total bilirubin less than 1.5mg/dL - Creatine less than 1.5 mg/dL - Alkaline phosphatase less than 2.5X upper limit of normal - Life expectancy of at least 12 weeks - ECOG performance status of 0-1 - Patient must provide informed consent - Patient must provide authorization to disclose Exclusion Criteria: - Evidence of active brain metastases - The only evidence of metastasis is lytic or blastic bone metastases - Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2 - Received radiotherapy in last 4wks, except if to a non-target lesion only - Clinically significant concurrent illness - Investigator's opinion that patient unlikely to complete study - Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks - History of allergy/hypersensitivity to study drug - Serious Medical Risk Factors determine by the investigator


NCT ID:

NCT00093119


Primary Contact:

Study Director
Michael Hawkins
Abraxis BioScience, LLC.


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27703
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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