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

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell cancer (RCC)

• Clear-cell subtype with a resectable asymptomatic in situ primary

• Asymptomatic primary is defined as the absence of symptoms* which can be exclusively assigned to the primary tumor such as flank pain and/or gross hematuria necessitating blood transfusion NOTE: *Para-neoplastic symptoms cannot be assigned to the primary tumor alone in metastatic disease, they are not included in this definition.

• No symptomatic primary tumor necessitating nephrectomy

• Resectable primary tumor

• Bulky locoregional lymph node metastases larger than the primary tumor allowed provided resectability of the lymph nodes is surgically feasible

• Metastatic RCC

• Distant metastases are not completely resectable at the time of surgery or during an additional intervention

• No multiple distant lesions at one site

• No bone-only metastases

• Measurable disease, both primary and metastatic, according to RECIST 1.1 criteria

• Planning to receive sunitinib malate as background therapy

• Patients with > 3 of the following surgical risk factors are not eligible:

• 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