Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

Inclusion Criteria:1. Histologically or cytologically confirmed metastatic or unresectable renal cell carcinoma (RCC). Patients must have a component of conventional clear cell renal carcinoma.

2. No more than one prior systemic therapy. No prior vascular endothelial growth factor receptor agents.

3. Patients with their primary tumor in place who are appropriate surgical candidates are strongly encouraged (but not required) to undergo nephrectomy 4. Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided the Subject has at least one measurable and/or evaluable lesion(s) that has not been irradiated.

5. All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to Day 1 dosing. Patients must have recovered from surgery and/or radiotherapy toxicity prior to Day 1 dosing.

6. Measureable disease by RECIST criteria 7. Karnofsky performance status >= 70% or ECOG <=2 8. Ability to give written informed consent 9. >= 18 years old 10. Female subjects of childbearing potential must have a negative pregnancy test within 7 days of Day 1 dosing.

11. Sexually active fertile subjects must use an accepted method of contraception during the course of the study and three months thereafter.

12. Subjects with organ and marrow function as follows: ANC >= 1,500/uL Platelet Count >= 100,000/uL AST/ALT <= 2.5 times the upper limit of normal (ULN) Alk. Phosphatase. <= 2.5 x ULN Serum bilirubin <= 1.5 x ULN Amylase/Lipase within normal range Urinalysis <= 1+ protein Pregnancy test for (females Negative of childbearing potential) Serum creatinine <= 1.5 x ULN

ECG, no active ischemia Echocardiogram or MUGA ejection fraction >= 40%

Exclusion Criteria:1. Subjects with ongoing hemoptysis, cerebrovascular accident within 12 months, peripheral vascular disease with claudication on less than 1 block, or history of clinically significant bleeding.

2. Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible.

3. Subjects with deep venous thrombosis or pulmonary embolus within one year of consent. Subjects with ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed.

4. Subjects with evidence of current central nervous system (CNS) metastases. All patients must undergo an MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing.

5. Subjects with significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV), angina pectoris requiring nitrate therapy, or recent myocardial infarction (within the last 6 months).

6. Subjects with uncontrolled hypertension (defined as blood pressure of >= 160 mmHg systolic and/or >= 90 mmHg diastolic on medication).

7. Subjects with an ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.

8. Subject with an uncontrolled psychiatric disorder 9. Subjects with delayed healing of wounds, ulcers, and/or bone fractures are not eligible.

10. Prior malignancy with the following exceptions: adequately treated basal cell or squamous cell skin cancer, as well as any other cancer for which chemotherapy has been completed >5 years ago and from which the patient has been disease-free for > 5 years 11. Pregnant or lactating women. 12. Subjects currently using the herb , St. John's Wort