ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed melanoma
• •* Inoperable locally recurrent or metastatic disease
• •Measurable disease
• •* No lytic or blastic bone metastasis as only evidence of metastasis
• •* Prior radiotherapy to a target lesion allowed provided there has been clear progression of disease since completion of radiotherapy
• •No active brain metastasis, including leptomeningeal involvement
• •* Prior brain metastasis allowed provided the disease is in complete remission for at least 1 month after therapy
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-1
• •Life expectancy
• •More than 12 weeks
• •Hematopoietic
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9 g/dL
• •Hepatic
• •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• •Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)
• •Bilirubin ≤ 1.5 mg/dL
• •Renal
• •Creatinine ≤ 1.5 mg/dL
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception 1 month before and during study participation
• •No pre-existing peripheral neuropathy ≥ grade 2
• •No prior allergy or hypersensitivity to study drug
• •No concurrent clinically significant illness
• •No other concurrent active malignancy
• •No serious medical risk factors involving any of the major organ systems that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •Recovered from prior chemotherapy
• •More than 4 weeks since prior cytotoxic chemotherapy
• •At least 3 weeks since prior anthracyclines
• •No concurrent taxane or anthracyclines
• •No concurrent doxorubicin
• •Endocrine therapy
• •No concurrent steroids except as needed for hypersensitivity to study drug
• •Radiotherapy
• •See Disease Characteristics
• •Concurrent radiotherapy to a symptomatic non-target lesion (including recurrent or new brain metastases that develop during study participation) allowed
• •Surgery
• •Not specified
• •Other
• •More than 4 weeks since prior investigational drugs and recovered
• •No other concurrent anticancer therapy
• •No concurrent participation in another clinical study
• •No other concurrent investigational therapies
• •No concurrent ritonavir, saquinavir, indinavir, or nelfinavir