A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma
OBJECTIVES:
Primary
- Evaluate the safety and toxicity of dose escalating sorafenib tosylate in patients with
metastatic or unresectable renal cell carcinoma.
Secondary
- Determine tumor response in these patients.
- Determine time to progression in these patients.
- Determine overall survival of these patients.
Tertiary
- Collect data on angiogenesis inhibition induced by sorafenib tosylate.
- Collect data on immunomodulatory effects of sorafenib tosylate.
OUTLINE: This is an open-label study.
Patients receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4
weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients receive escalating doses of sorafenib tosylate (in the absence of grade 3 or 4
dose-limiting toxicity) until a pre-determined dose is reached.
Blood and urine samples are collected at baseline and periodically during study for VEGF
level determination. Blood samples are analyzed for T4/T8, NK, CD25+, and Fox p3 by flow
cytometry. Tumor tissue blocks or unstained slides are obtained for chemistry staining of
VEGF.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity of intrapatient dose escalation of sorafenib tosylate
To evaluate the toxicity of dose escalating sorafenib, an estimation of the percentage of patients who are unable to tolerate those escalated doses will be made. Patients will be dose escalated every 4 weeks until a maximum dose of 800 mg BID is reached.
Study completion
Yes
Ralph Hauke, MD
Principal Investigator
University of Nebraska
United States: Food and Drug Administration
081-06
NCT00496756
March 2007
January 2015
Name | Location |
---|---|
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |