An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma

Fecha de inicio: 1 de febrero de 2004

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