Renal Cell Carcinoma Clinical Trial
Official title:
A Phase I/II Study of Sorafenib and Palliative Radiotherapy in Patients With Advanced Renal Cell Carcinoma and Symptomatic Bony Metastases
The purpose of this study is to investigate the use of a new anti-angiogenic drug called
sorafenib, in combination with radiotherapy, for renal cell cancer that has spread to the
bone and is causing significant pain. The study will find a safe dose of sorafenib for this
combination study treatment, look at side effects, and test if the study treatment is
effective in controlling the pain experienced from this type of renal cell cancer. . There
will be two parts or phases to this study
The purpose of the first phase is to find the highest dose of sorafenib that can be given
safely to patients, when combined with radiotherapy. We will also see what kind of effects
the study treatment has on you and your cancer. Participants in this phase will receive a
dose of sorafenib that has shown to be well-tolerated in humans. If the side effects are
tolerable for this dose of sorafenib when combined with radiotherapy, new patients will be
asked to join the study and will receive a dose of sorafenib higher than the last study
participant.
In the second phase, new study participants will receive the dose of sorafenib that was
determined to be safe in the first phase. Side effects will continue to be looked at and the
effectiveness on controlling pain symptoms from this type of cancer, will also be looked at.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label
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