A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University
1. Histologically or cytologically confirmed metastatic or unresectable
renal cell carcinoma (RCC). Patients must have a component of conventional clear cell
2. No more than one prior systemic therapy. No prior vascular endothelial growth factor
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
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
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
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