Intervention: Sorafenib
Trial phase: Not Applicable
ATC code: L01EX02 | L01XE05
SMILES: CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Sorafenib 400mg orally twice daily on days 1-28

sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days

diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed newly diagnosed clear cell renal cell carcinoma, meeting 1 of the following criteria:

Localized disease, as evidenced by intact, bulky, and primary renal lesions (T1 > 3 cm, any T2, T3, or T4) appropriate for nephrectomy
Limited metastatic disease, as evidenced by any renal primary (T1 > 3 cm, any T2, T3, or T4) appropriate for cytoreductive nephrectomy
Isolated abdominal/pelvic recurrence with limited metastatic burden (minimum size > 2 cm) appropriate for metastasectomy

No known brain metastasis

Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group performance status 0-1
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
Alanine aminotransferase and Aspartate aminotransferase ≤ 2.5 times ULN (≤ 5 times ULN with liver involvement)
Creatinine ≤ 1.5 times ULN
Estimated glomerular filtration rate > 30 mL/min (for patients receiving Gd-enhanced MRI)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception prior to, during (men and women), and for at least 3 months after (men) completion of study therapy
Adequate cardiac and pulmonary status for operative therapy
No active clinically serious infection > CTCAE grade 2
No known HIV, hepatitis B, or hepatitis C infections
No serious non-healing wound, ulcer, or bone fracture
No significant traumatic injury within the past 4 weeks
No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks

No history of an uncontrolled bleeding disorder including, but not limited to, any of the following:

Bleeding diathesis
Coagulopathy

No cardiac disease or condition including, but not limited to, any of the following:

New York Heart Association class II-IV congestive heart failure
Unstable angina (anginal symptoms at rest)
New onset angina beginning within the last 3 months
Myocardial infarction within the past 6 months
Cardiac ventricular arrhythmias requiring antiarrhythmic therapy
No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical management
No thrombolic or embolic events within the past 6 months (e.g., cerebrovascular accident including transient ischemic attacks)
No condition that impairs the ability to swallow whole pills
No malabsorption problem

No contraindication to MRI, including, but not limited to, any of the following:

Ferromagnetic implants
Dental work
Pacemakers
Metallic implants
Severe claustrophobia which precludes closed MRI testing
No known or suspected allergy to sorafenib tosylate
No contraindication or allergy to gadolinium (e.g., end stage renal disease requiring hemodialysis)
No intercurrent illness or situation which, in the judgment of the investigator, would affect assessments of clinical status and study endpoints significantly

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 4 weeks since prior major surgery or open biopsy
No prior therapy with tyrosine kinase or vascular endothelial growth factor inhibitors (e.g., sunitinib malate, sorafenib, or bevacizumab)
No concurrent Hypericum perforatum (St. John's wort) or rifampin
No concurrent use of illicit drugs or other substances that may, in the opinion of the investigator, have a reasonable chance of contributing to toxicity or interfering with study results