Bevacizumab and Temozolomide or Bevacizumab and Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed by Surgery

Inclusion Criteria

• •Histologic confirmed diagnosis of malignant melanoma
• •* Stage IV disease
• •* Not amenable tosurgery
• •Measurable disease with at least one lesion whose longest diameter canbe measured as ≥ 20 mm by CT or MRI scans OR ≥ 10 mm by spiral CT
• •* No disease that is measurable by physical examination only
• •No brain metastases per MRI or CT
• •No radiographically documented invasion of adjacent organs(duodenum, stomach, etc.) or tumor invading major blood vessels
• •ECOG performance status 0-1
• •Life expectancy ≥ 4 months
• •ANC ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Hemoglobin ≥ 9 g/dL (transfusion allowed)
• •Creatinine ≤ 1.5 times upper limit of normal (ULN)
• •Total bilirubin ≤ 1.5 mg/dL (unless Gilbert syndrome)
• •AST ≤ 2.5 times ULN
• •Alkaline phosphatase ≤ 2.5 times ULN
• •Urine protein:creatinine ratio \< 1.0 at screening ORproteinuria \< 2+ by urine dipstick or protein ≤ 1 g by 24-hour urine collection
• •Negative serum pregnancy test
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •Active infection requiring parenteral antibiotics
• •Poorly controlled high blood pressure (≥ 150 mm Hg systolic and/or100 mm Hg diastolic) despite treatment
• •NYHA class II-IV congestive heart failure
• •Serious cardiac arrhythmia requiring medication
• •Myocardial infarction or unstable angina within the past 6 months
• •Clinically significant peripheral vascular disease
• •Deep venous thrombosis or pulmonary embolus within the past year
• •Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices)
• •Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture
• •Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 6 months
• •History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.)
• •Clinically significant stroke or TIA within the past 6 months
• •Seizures not controlled with standardmedical therapy
• •Peripheral neuropathy ≥ grade 2
• •History of other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treatable with local resection only or carcinoma in situ of the cervix
• •Significant traumatic injury within the past 4 weeks
• •History of hypertensive crisis or hypertensive encephalopathy
• •Active or recent (≤ 30 days) history of hemoptysis (≥ ½ teaspoon of bright red blood per episode)
• •Known hypersensitivity to any of the components of bevacizumab
• •Known to be HIV positive
• •Current or known history of hepatitis
• •Prior adjuvant chemotherapy and/or immunotherapy for this cancer allowed
• •No prior treatment with agents disrupting VEGF activity (i.e., bevacizumab,VEGF-trap, anti-VEGFR Mab)
• •No ongoing need for full-dose oral or parenteral anticoagulation
• •No ongoing anti-platelet treatment other than low-dose aspirin(i.e., aspirin 81 mg daily)
• •No other investigational agents within the past 4 weeks
• •No major surgical procedure or open biopsy within the past 4 weeks
• •No fine needle aspirations or core biopsies within the past 7 days
• •No prior chemotherapy in the metastatic setting
• •No prior treatment with sunitinib malate or sorafenib
• •No prior treatment with any taxane-based chemotherapy