| Exclusion Criteria: | 1) Prior treatment for metastatic disease with chemotherapy or biologic therapy (adjuvant systemic therapy is acceptable if it was used prior to Stage IV disease and was discontinued >/= 4 months prior to Day 1; BCG, GM-CSF, or vaccine therapy following complete surgical resection or complete irradiation/radiofrequency ablation of Stage IV disease prior to disease progression is also acceptable.)
2) Complete surgical resection or irradiation of all identifiable sites of disease at randomization
3) Radiation therapy within 14 days prior to Day 1
4) Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy.
5) Melanoma of ocular origin.
6) Known CNS disease/brain metastases (history of brain disease or active disease).
7) Life expectancy of less than 12 weeks.
8) Current, recent (within 4 weeks), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
9) Inadequate organ function, as evidence by any of the following laboratory values - Absolute neutrophil count less than 1500/uL- Platelet count less than 100,00/uL- Total bilirubin greater than 1.5 mg/dL- Alkaline phosphatase, AST, and/or ALT greater than 2 x the upper limit of normal - Serum creatinine greater than 1.5 mg/dL - International normalized ratio (INR) greater than 1.5 the ULN and/or activated partial thromboplastine time (aPTT) greater than 1.5 x the ULN
10) History of other malignancies within 5 years of Day 1, except for tumors with a neglible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
11) Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.
12) Inadequately controlled hypertension greater than 140 mmHg and/or distolic blood pressure greater than 90 mmHg on anti-hypertensive medications)
13) History of hypertensive crisis or hypertensive encephalopathy
14) New York Heart Association Class II or greater CHF
15) History of myocardial infarction or unstable angina within 6 months prior to Day 1
16) History of stroke or transient ischemic attack within 6 months prior to Day 1
17) Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to Day 1
18) History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
19) Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
20) Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anaticipation of need for major surgical procedure during the course of the study.
21) Minor surgical procedures, fine-needle aspirations, or core biopsies within 7 days prior to Day 1
22) History of abdominal fistula or gastrointestinal perforation with 6 months prior to Day 1
23) Serious, non-healing wound, active ulcer, or untreated bone fracture. Patients with fractures secondary to metastatic disease are eligible after appropriate radiotherapy.
24) Proteinuria at screening, as demonstrated by a urine protein/creatinine ration of greater than or equal to 1.0 at screening
25) Known hypersensitivity to any component of bevacizumab
26) Pregnancy (positive pregnancy test) or lactation. Patients of childbearing potential must use an effective means of contraception (men and women).
27) Current, ongoing treatment with full-dose warfarin |