Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
Phase 2
Completed
- Conditions
- MelanomaMetastases
- Registration Number
- NCT00093119
- Lead Sponsor
- Celgene
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
- Secondary Outcome Measures
Name Time Method Evaluate number of cycles required before patients achieve maximum response
Trial Locations
- Locations (1)
Abraxis BioScience Inc.
🇺🇸Durham, North Carolina, United States
Abraxis BioScience Inc.🇺🇸Durham, North Carolina, United States