Personalized Targeted Inhibitors Treatment in Renal Cell Cancer

Inclusion Criteria

• •* Pathologically confirmed renal cell carcinoma.
• •* No prior systemic and/or investigative therapy of any kind.
• •* Patients with primary tumor in place are strongly encouraged to undergo nephrectomy prior to initiation of study agent.
• •* Prior palliative radiotherapy to metastatic lesion(s) is permitted. Patient must have adequately recovered from the acute toxicities of this treatment.
• •* All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to registration.
• •* Must have progressive metastatic disease
• •* ECOG performance status ≤2
• •* Women of childbearing potential and male patients must use acceptable methods of contraception-tubal ligation, vasectomy, barrier contraceptive with spermicide-while on study and for 3 months after the last dose of study therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
• •* Age ≥18 years
• •* Required Initial Laboratory Values:
• •* Granulocytes ≥1,500/µL
• •* Platelet Count ≥100,000/µL
• •* Hemoglobin ≥9 g/dL
• •* AST/ALT ≤ 2.5 times the upper limit of normal (ULN)
• •* Alk. Phos.≤ 2.5 x ULN
• •* Serum bilirubin ≤ 1.5 x ULN
• •* Amylase/Lipase within normal range
• •* Urinalysis≤ 1+ protein
• •* T3T4 TSH - within normal range
• •* Pregnancy test for women - Negative
• •* Serum creatinine ≤ 1.5 x ULN
• •* Electrocardiogram (ECG) - no active ischemia
• •* Echocardiogram ejection fraction ≥40%
• •* Pulmonary function tests
• •* Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
• •* Signed informed consent prior to the performance of any study-specific procedures