Efficacy Study of Sunitinib and Everolimus (Rotational vs Sequential Arm) in Pats. With m Clear Cell Renal Cancer

Exclusion Criteria

• •Prior treatment with VEGF-targeting agents or multi-kinase inhibitors or mTOR-targeting agents
• •Active central nervous system metastases.
• •Other malignancy diagnosed within the last 5 years, except the following if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (T1 and G1 or T1 and G2), stage 1 cervical cancer.
• •Treatment with an investigational agent in the last 4 w.
• •Known to be HIV positive.
• •Evidence of chronic hepatitis due to hepatitis B virus (HBV) or hepatitis C virus (HCV)
• •Clinically significant heart disease (NYHA Class III or IV)
• •History of hypertension requiring hospitalization.
• •Other serious illnesses,
• •Immunotherapy or chemotherapy in the last 4 w (6 weeks for nitrosoureas)
• •Major surgery in the last 4 w, or planned in the next 6 w
• •Radiation therapy in the last 2 w, or planned in the next 6 w
• •NCI CTCAE (Common Toxicity Criteria for Adverse Effects) version 4.0 grade 3 or worse hemorrhage in last 4 w.
• •Any of the following in the last year: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
• •Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
• •Ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 grade ≥2, atrial fibrillation of any grade, or prolongation of the corrected QT interval (QTc) to \>450 msec for males or \>470 msec for females
• •Uncontrolled diabetes as defined by fasting serum glucose \>1.5 X ULN.
• •Pregnancy,lactation. Inadequate contraception.
• •Known allergy or hypersensitivity to everolimus, sunitinib or iodine.
• •Medical or psychiatric condition that compromises the patient's ability to give informed consent.