Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

Inclusion Criteria:

Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).
must have a component of conventional clear cell renal carcinoma.
No more than one prior systemic therapy.
No prior vascular endothelial growth factor receptor agents.
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.
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.
Measureable disease by RECIST criteria
Karnofsky performance status at least 70% or ECOG not more than 2
Ability to give written informed consent
At least 18 years old
Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing potential)
Sexually active fertile subjects must agree to use an accepted method of contraception during the course of the study for 3 months thereafter.
ANC at least 1,500/uL
Platelet count at least 100,000/uL
AST/ALT not more than 2.5 times the upper limit of normal (ULN)
Alkaline phosphatase not more than 2.5 x ULN
Serum bilirubin not more than 1.5 x ULN
Amylase/Lipase within normal range
Urinalysis not more than 1+ protein
Serum creatinine not more than 1.5 x ULN
No active ischemia by ECG
Echocardiogram or MUGA ejection fraction at least 40%

Exclusion Criteria:

Ongoing hemoptysis
Cerebrovascular accident within 12 months
Peripheral vascular disease with claudication on less than 1 block
History of clinically significant bleeding
Malignancy with true papillary/sarcomatoid features without any clear cell component
Chromophobe
Oncocytoma
Collecting duct tumors
Transitional cell carcinoma
Deep venous thrombosis or pulmonary embolus within one year of consent
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
Subjects with evidence of current central nervous system (CNS) metastases
MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing
Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV)
Angina pectoris requiring nitrate therapy
Myocardial infarction within the last 6 months
Uncontrolled hypertension (defined as blood pressure at least 160 mmHg systolic or at least 90 mmHg diastolic on medication)
Ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.
Uncontrolled psychiatric disorder
Delayed healing of wounds, ulcers, and/or bone fractures
Prior malignancy (EXCEPTIONS: adequately-treated basal cell or squamous cell skin cancer or any other cancer for which chemotherapy has been completed > 5 years ago and from which the patient has been disease-free for > 5 years)
Pregnant
Currently lactating
Currently using St John's Wort (an herb)