Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination with Carboplatin and Paclitaxel in Patients with Metastatic Uveal Melanoma

Pts must have Stage IV metastatic uveal melanoma; one prior systemic regimen for Stage IV melanoma; prior tx must have been completed 28 days prior to registration; Zubrod PS of 0 or 1; ANC > 1,500/mm3 platelet count > 100,000/mm3; serum creatinine <= 2x IULN; SGOT or SGPT <= 2x IULN (or <= 5x IULN, if hepatic metastasis is present) obtained within 28 prior to registration; Pts on full-dose anticoagulants are eligible if pt has in-range INR (usually between 2 and 3) within 28 days prior to registration and no active bleeding or pathological condition with high risk of bleeding; Pts must not have evidence of bleeding diathesis or active coagulopathy with high risk of bleeding; Pts must not have hypertension (systolic blood pressure of > 140 mmHg or diastolic pressure > 90 mmHg); No major surgery or traumatic injury within 21 days prior to treatment; Pts must not have previously received BAY 43-9006 or other agents targeting raf or VEGF/VEGFR; Pts must be able to swallow pills; Pts must be 18 yrs of age or older; Pts must not plan to receive systemic corticosteroid therapy (topical and/or inhaled steroids are allowed); Pts must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin or St. John's Wort; Pts must not be pregnant or nursing; Pts must not have prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical, Stage I or II ca in complete remission and disease-free from ca for 5 yrs