Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer

Exclusion Criteria

• •* Serum albumin CTCAE v 4.0 grade 2 or worse
• •* Serum LDH \> 1.5 times upper limit of normal
• •* Liver metastases
• •* Symptoms at presentation due to metastases
• •* Retroperitoneal lymph node involvement
• •* Supra-diaphragmatic lymph node involvement
• •* Clinical stage T3 or T4 disease
• •No clinical signs of CNS involvement
• •PATIENT CHARACTERISTICS:
• •See Disease Characteristics
• •WHO performance status 0-1
• •Life expectancy \> 3 months
• •WBC \> 3.0 x 10\^9/L
• •Platelet count \> 100 x 10\^9/L
• •Hemoglobin \> 10.0 g/dL
• •PT/PTT or INR ≤ 1.2 times upper limit of normal (ULN)
• •Bilirubin ≤ 1.5 times ULN
• •ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver lesions)
• •Serum calcium \< 10.0 mg/dL
• •Calculated or measured creatinine clearance \> 30 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception 2 weeks before and during study treatment
• •LVEF normal by MUGA scan or ECHO
• •12-lead ECG normal
• •No serious cardiac illness (myocardial infarction and/or treatable or untreatable angina pectoris not responding to treatment) within the past 12 months
• •No uncontrolled, high BP (≥ 150/100 mm Hg) despite optimal medical therapy
• •No current pulmonary disease
• •No active or uncontrolled infections, serious illnesses, malabsorption syndrome, or medical conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV, and/or cirrhosis
• •No malignancies within the past 5 years except renal cell carcinoma, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, resected incidental prostate cancer staged pT2 with Gleason Score ≤ 6 and postoperative PSA \< 0.5 ng/mL, or patients with any history of malignancies who are disease-free for more than 5 years
• •No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• •PRIOR CONCURRENT THERAPY:
• •Prior local radiotherapy for bone lesions allowed
• •No prior systemic therapy for metastatic RCC
• •No prior partial or total nephrectomy
• •No concurrent systemic corticosteroid and/or other immunosuppressive systemic therapies
• •No concurrent radiotherapy, except palliative radiotherapy
• •No concurrent participation in another clinical trial testing treatments for any disease including renal cell carcinoma
• •No other concurrent investigational or systemic therapy for metastatic RCC