Carcinoma, Renal Cell Clinical Trial
Official title:
A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma
The purpose of this study is to determine the safety and toxicity levels of Dose Escalated Sorafenib in the treatment of patients with renal cancer.
Because tumors may have multiple mechanisms to induce angiogenesis, blockade with sorafenib
may demonstrate efficacy. Doses of sorafenib (400 mg b.i.d.) as a single agent is with
minimal toxicity, presents an opportunity to explore a more intensive drug administration.
This study will allow individual patient titration (e,g,, intrapatient dose escalation) as
per protocol.
This provides the basis for the dose escalation development of sorafenib. The study is
designed to evaluate the ability for patients to dose escalate. Secondary endpoints include;
response, time to progression, and overall survival in patients with MRCC. Tissue
correlation to evaluate the impact of expression of receptor on clinical outcome will be
retrospectively performed. Laboratory correlation of plasma VEGF levels will be correlated
and evaluated to clinical outcome.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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