A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Sorafenib
Phase: Phase 2
Ages Eligible For Study:
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%