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Study Title: Temsirolimus and Sorafenib as Second-Line Therapy in Patients With Advanced RCC Who Failed First-Line Sunitinib
Category: Cancer, General

Currently accepting participants?
Yes - please read the description below and contact the study coordinator if you are interested.

Principal Investigator: Jacqueline Vuky
Study Coordinator: Erika Douglass
Phone: (206) 625-7373 Ext.64535
Email: erika.douglass@vmmc.org

What is the Temsirolimus and Sorafenib as Second-Line Therapy in Patients With Advanced RCC Who Failed First-Line Sunitinib study?

Wyeth is sponsoring this study for people diagnosed with advanced kidney cancer, also known as metastatic renal cell carcinoma, whoes disease condition has gotten worse while being treated with Sutent. The purpose of this study is to learn whether Torisel and Nexavar are safe and useful in treating advanced kidney cancer when given after treatment with Sutent fails. This is an open label study which means that both you and your doctor will know what medication you are being given.

Who can participate?

18 years and older
diagnosid with metastatic renal cell carcinoma
must have completed at least one 6 week cycle of
Sutent
At least one lesion that can be measured by CAT scan
Good heart and lung function
no metastisis to the central nervous system
no previous treatment for renal cell carcinoma
other then sutent
Serious medical condtions - to be determined by
study doctor

What do I have to do as a study participant?

If you are assigned to receive Torisel, you will
be given 25 mg of Torisel through a needle in your
vein at your study doctors office once per week
over a period of 30-60 minutes. Thirty minutes
before you are given the Torisel, you will be
given 25 to 50 mg of an antihistamine such as
Benadryl through your vein. If you experience any
unacceptable side effects from the Torisel, the
study doctor may decrease the dose as needed.

If you are assigned to receive Nexavar, you will
take 2 tablets by mouth twice a day at home for a
total dose of 800 mg per day. If you experience
any unacceptable side effects from the Nexavar,
the study doctor may decrease the dose as needed.

You will have an equal chance of receiving either
of the study medications. Every 6 weeks that you
are taking the study medications will be called a
cycle. You will have weekly contact with the
study coordinator, either at office visits or by
phone. They number of office visits vary
depending on what drug you are assigned to. You
will have various blood tests, physical exams, and
CT scans through out the study, as well as test to
measure your heart function.

Study Summary:

Detailed Study Description:

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