Renal Cell Cancer Clinical Trial
Official title:
A Phase II Study of the Efficacy and Tolerability of the Dose Escalation of Sorafenib in Advanced Renal Cell Cancer
The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a significant increase in side effects.
In 2006, an estimated 38,890 people in the United States were diagnosed with kidney cancer
and greater than 12,000 died from the disease. Kidney cancer that has spread to other parts
of the body is one of the most treatment-resistant diseases. Standard of care treatment
usually involves chemotherapy. Results from chemotherapy have been disappointing. Therefore,
there is a need to develop additional safe and effective therapies to treat advanced kidney
cancer.
Sorafenib (Nexavar®) has been approved by the FDA for the treatment of advanced kidney
cancer. Sorafenib works by interfering with a type of protein in your body that determines
how your kidney cells work and grow. Sorafenib at standard doses for 400mg(two pills)
twice/day, given seven days/week, may slow progression of the disease for an average of
three months but it is not expected to be curative. Preliminary studies have suggested
higher doses of sorafenib may increase the chance that the tumor will shrink.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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