Status:
COMPLETED
Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
Lead Sponsor:
Celgene
Conditions:
Melanoma
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00093119
Start Date
July 1 2003
Last Update
April 26 2017
Active Locations (1)
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1
Abraxis BioScience Inc.
Durham, North Carolina, United States, 27703