Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery

Inclusion Criteria:

• Histologically or cytologically confirmed evidence of metastatic/ unresectable uveal melanoma
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension and is ≥10 mm by spiral CT scan
• 18 years or older
• Eastern Cooperative Oncology Group(ECOG)performance status 0, or 1
• No known HIV or Hepatitis B or C
• Patients with brain metastasis are eligible for entry into the study

• Patients must have normal organ/marrow function as defined below:

  • Absolute neutrophil count ≥ 1.5 x 109/L
  • Platelets ≥ 100,000 x 109/L
  • Hemoglobin ≥ 9.0 gm/100 ml
  • Total bilirubin ≤ 1.5. In patients with Gilbert's disease the indirect bilirubin must be less than or equal to 4.0.
  • AST and ALT ≤ 2.5x upper limit of normal
  • Alkaline phosphatase ≤ 2.5x upper limit of normal, unless bone metastases is present in the absence of liver metastasis
  • Creatinine ≤ 1.8 mg/ml or calculated creatinine clearance > 50 mg ml.
  • Calcium <12 mg/dl when corrected for levels of serum albumen
• Patients my have had up to one prior systemic therapy

Exclusion Criteria:

• Chemotherapy or radiotherapy within 4 weeks prior to entering the study or failure to recover from adverse events due to agents administered more than 4 weeks earlier.
• May not be receiving any other simultaneous investigational agents
• No prior malignancy except for adequately treated basal cell cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years.
• Patients who have serious infections or other major uncontrolled medical illnesses.
• Patients who have significant psychiatric illness who in the opinion of the principal investigator would prevent adequate informed consent or render therapy unsafe.
• Patients who are pregnant. Female patients of child bearing potential must have a negative serum pregnancy test and use adequate contraception protection while on study.
• Peripheral neuropathy of > grade 2.