A Phase II Trial of Carboplatin (CBDCA) and ABI-007(ABX) in Patients With Unresectable Stage IV Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed unresectable stage IV melanoma

- Measurable disease

- Must have formalin-fixed, paraffin-embedded tumor tissue available for secreted
protein acidic and rich in cysteine (SPARC) analysis pre-treatment (Mayo Clinic
patients must be willing to submit a repeat biopsy at time of tumor progression)

- Brain metastases allowed provided they were previously treated with no progression
for ≥ 3 months

- Patients with known brain metastases may receive concurrent steroid treatment

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL (may be transfused to meet this requirement)

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 times ULN (elevated bilirubin allowed in patients with
documented Gilbert's syndrome)

- AST ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after
completion of study therapy

- No uncontrolled intercurrent illness including, but not limited to, the following:

- Active infection

- Congestive heart failure (New York Heart Association class III-IV heart disease)

- No peripheral neuropathy ≥ grade 2

- No other malignancy within the past 5 years except basal cell or squamous cell
carcinoma of the skin previously treated with local resection only or carcinoma in
situ of the cervix

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior therapy

- At least 4 weeks since prior radiotherapy

- At least 4 weeks since prior interferon or interleukin-2

- At least 4 weeks since prior chemotherapy (cohort 1 )

- No prior chemotherapy in the metastatic setting (cohort 2)

- No prior treatment for melanoma with any of the following agents:

- Platinum chemotherapy (e.g., carboplatin or cisplatin)

- Taxanes (e.g., paclitaxel or docetaxel)

- Paclitaxel albumin-stabilized nanoparticle formulation (ABI-007)

- No other concurrent chemotherapy

- No other concurrent investigational agents

- No concurrent radiotherapy, including palliative radiotherapy