Bevacizumab and Sunitinib in Treating Patients With Solid Tumors

You may be eligible if

• Histologically proven metastatic/unresectable adrenocortical carcinoma or melanoma not amenable to curative surgical or radiation therapy.
• Accrual closed as of 5/27/2009 to patients with renal cell carcinoma
• No squamous cell histology
• No histology in close proximity to a major blood vessel
• No history of or known brain metastases, spinal cord compression, or carcinomatous meningitis
• No new evidence of brain or leptomeningeal disease on screening CT scan or MRI
• ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥100,000/mm³
• Hemoglobin ≥ 10.0 g/dL
• Calcium ≤ 12.0 mg/dL
• Urine protein:creatinine ratio ≤ 0.5 by urinalysis
• Patients with urine protein:creatinine ratio \> 0.5 must have proteinuria \< 1,000 mg by 24-hour urine collection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
• None of the following within the past 12 months:
• * Myocardial infarction
• * Severe/unstable angina
• * Severe peripheral vascular disease (claudication) or procedure on peripheral vasculature
• * Coronary/peripheral artery bypass graft
• * New York Heart Association (NYHA) grade III-IV congestive heart failure
• * Cerebrovascular accident or transient ischemic attack
• * Clinically significant bleeding
• * Deep venous thrombosis
• * Pulmonary embolism
• * No ongoing cardiac dysrhythmias of NCI CTCAE ≥ grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to \> 450 msec (males) or \> 470 msec (females)
• * No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
• * No condition classified as NYHA grade III or IV
• * No hypertension that cannot be controlled by medications
• * Blood pressure \< 140/90 mm Hg
• * No evidence of bleeding diathesis or coagulopathy
• * No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• * No history of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan unless without progression on \* MRI or CT for 3 months."
• * No significant traumatic injury within the past 28 days
• * No serious, non-healing wound, ulcer, or bone fracture
• * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• * No known HIV or AIDS-related illness
• * No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation.
• Recovered from prior radiation therapy, surgery, or other prior therapy
• No prior bevacizumab or sunitinib malate (SU11248)
• Other antiangiogenic therapies allowed
• No prior tyrosine kinase inhibitor of the VEGF receptor or bevacizumab for patients with metastatic renal cell carcinoma
• No major surgical procedures or open biopsy within the past 28 days
• No core biopsy within the past 7 days
• No radiation therapy or systemic therapy within the past 4 weeks
• No concurrent full-dose anticoagulants (e.g., warfarin)
• Concurrent low-dose anticoagulation (e.g., prophylactic port patency) allowed
• No concurrent treatment on another clinical trial
• No other concurrent investigational drugs
• No concurrent major surgery
• No other concurrent anticancer agents or therapies, including chemotherapy, biological response modifiers, hormonal therapy, surgery, palliative radiation therapy, or immunotherapy