©2024 Stanford Medicine
Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
Not Recruiting
Trial ID: NCT00854620
Purpose
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with
progressive metastatic renal cell carcinoma treated with sorafenib
Official Title
A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
Inclusion Criteria:
1. Histologically- or cytologically-confirmed metastatic or unresectable renal cell
carcinoma (RCC).
2. must have a component of conventional clear cell renal carcinoma.
3. No more than one prior systemic therapy.
4. No prior vascular endothelial growth factor receptor agents.
5. 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.
6. 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.
7. Measureable disease by RECIST criteria
8. Karnofsky performance status at least 70% or ECOG not more than 2
9. Ability to give written informed consent
10. At least 18 years old
11. Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing
potential)
12. Sexually active fertile subjects must agree to use an accepted method of contraception
during the course of the study for 3 months thereafter.
13. ANC at least 1,500/uL
14. Platelet count at least 100,000/uL
15. AST/ALT not more than 2.5 times the upper limit of normal (ULN)
16. Alkaline phosphatase not more than 2.5 x ULN
17. Serum bilirubin not more than 1.5 x ULN
18. Amylase/Lipase within normal range
19. Urinalysis not more than 1+ protein
20. Serum creatinine not more than 1.5 x ULN
21. No active ischemia by ECG
22. Echocardiogram or MUGA ejection fraction at least 40%
Exclusion Criteria:
1. Ongoing hemoptysis
2. Cerebrovascular accident within 12 months
3. Peripheral vascular disease with claudication on less than 1 block
4. History of clinically significant bleeding
5. Malignancy with true papillary/sarcomatoid features without any clear cell component
6. Chromophobe
7. Oncocytoma
8. Collecting duct tumors
9. Transitional cell carcinoma
10. Deep venous thrombosis or pulmonary embolus within one year of consent
11. 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
12. Subjects with evidence of current central nervous system (CNS) metastases
13. MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1
dosing
14. Significant cardiovascular disease defined as congestive heart failure (New York Heart
Association Class II, II or IV)
15. Angina pectoris requiring nitrate therapy
16. Myocardial infarction within the last 6 months
17. Uncontrolled hypertension (defined as blood pressure at least 160 mmHg systolic or at
least 90 mmHg diastolic on medication)
18. Ongoing requirement for systemic corticosteroid therapy (except replacement therapy
for adrenal insufficiency). Topical and/or inhaled steroids are allowed.
19. Uncontrolled psychiatric disorder
20. Delayed healing of wounds, ulcers, and/or bone fractures
21. 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)
22. Pregnant
23. Currently lactating
24. Currently using St John's Wort (an herb)
Intervention(s):
drug: Sorafenib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Haas Denise
6507361252