• Progression-free survival [ Designated as safety issue: No ]
• Overall survival [ Designated as safety issue: No ]

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.

OBJECTIVES:

Primary

• To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation.

Secondary

• To determine the median progression-free survival of patients treated with this regimen.
• To determine the overall survival of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 8 weeks for 1 year.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed uveal melanoma

  • Unresectable, metastatic disease
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥ 10 mm by spiral CT scan

• Brain metastasis allowed provided the following criteria are met:

  • Definitively treated with radiotherapy or surgical resection
  • Stable disease as demonstrated by repeat MRI or head CT scans 4 weeks after completion of definitive therapy
  • No requirement for decadron

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy > 6 months
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Total bilirubin ≤ 1.5 mg/dL (indirect bilirubin ≤ 4.0 mg/dL for patients with Gilbert's disease)
• 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)
• Creatinine ≤ 1.8 mg/dL OR creatinine clearance > 50 mL/min
• Calcium < 12 mg/dL (corrected for serum albumin)
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV-negative
• Hepatitis B- or C-negative
• No prior malignancy except for adequately treated basal cell carcinoma of the skin, in situ cervical cancer, or other cancer for which the patient has been disease free for 2 years
• No serious infections or other major uncontrolled medical illnesses
• No significant psychiatric illness that, in the opinion of the principal investigator, would preclude adequate informed consent or render study therapy unsafe
• No peripheral neuropathy > grade 2

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No more than one prior systemic therapy
• Prior taxanes allowed provided there is disease progression > 12 months after completion of treatment
• More than 4 weeks since prior chemotherapy, radiotherapy, or surgery and recovered

• At least 4 months since prior chemoembolization or embolization of the liver

  • Disease must be present outside the embolized region of the liver for evaluation
• No other concurrent investigational agents

• National Cancer Institute (NCI)
• National Comprehensive Cancer Network