Inclusion Criteria:
- 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