Erlotinib and Bevacizumab in Treating Patients With Stage IV Melanoma

Inclusion Criteria

• Measurable Stage IV melanoma
• Easter Cooperative Oncology Group (ECOG) Performance Status must be 0-1
• Good organ function as demonstrated by, Creatinine 1500/ul, platelets>75k/ul, hemoglobin (Hgb)>9 (may be transfused to obtain)
• Prior therapy: adjuvant interferon (IFN) allowed; no more than one prior regimen for advanced stage IV disease
• Patients must have a life expectancy of >3 months
• Patients with brain metastases are eligible only if they fulfill the following: resected or stereotactic treatment a minimum of 3 months previously and no active CNS disease since then; brain metastases treated greater than 6 months ago without evidence of progression or hemorrhage, 2.0mg/dl, aspartate transaminase (AST) or alanine transaminase (ALT) >5 times upper limit of normal for subjects with documented liver metastases; >2.5 times the upper limit of normal (ULN) for subjects without evidence of liver metastases
• Patient may not be part of any other investigational studies
• internationalized normal ratio (INR) > 1.5
• Patients with PEG or G-tube are ineligible.
• Major surgical procedure, open biopsy; or significant traumatic injury within 28 days, or anticipation of need for major surgical procedure during the course of the study
• Any non-healing wound, ulcer, or bone fracture.
• Any clinical evidence or history of a bleeding diathesis or coagulopathy.
• Patients with a history of deep vein thrombosis or thromboembolic disease within the past 6 months.
• History of acute myocardial infarction within 6 months. In addition, patients are ineligible if they have clinically significant cardiovascular disease ((e.g., uncontrolled hypertension [blood pressure of >160/110 mmHg on medication], New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (Grade II or greater)
• Patients with > 1+ proteinuria will have 24-hour urine collection; for protein. Patients with ≥ 1gm protein/24 hrs will be excluded
• If child bearing age must not be pregnant or nursing and use methods to prevent pregnancy
• History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, or history of stroke)
• Inability to comply with study and/or follow-up procedures
• History of other disease, 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 might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.