Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/27/2017 |
| Start Date: | July 2003 |
A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
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.
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.
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
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