Paclitaxel Albumin-Stabilized Nanoparticle Formulation 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.

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.