IRB Number:

07-003605

Trial Status:

Open for Enrollment

Phase: IV

Why is this study being done?

Patients are being asked to take part in this research study because they have a disease called advanced renal cell carcinoma (RCC). Patients will be taking a drug called sorafenib (Nexavar). Sorafenib is an anti-cancer medication that is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of renal cell carcinoma.
The results of this study may help researchers understand how treating RCC patients with sorafenib may be linked to low phosphorous level in the blood, and how this low phosphorous level may or may not affect bone mineral density (BMD). Bone mineral density is a way of measuring bone strength. By measuring BMD it is possible to predict bone fracture risk in the same manner that measuring blood pressure can help predict the risk of stroke. The research staff also want to learn whether sorafenib treatment has any effect on the ability of the heart to pump blood efficiently.

Who is Eligible to Participate in the Study?

• Age 18 or older


• Diagnosed with advanced renal cell carcinoma (RCC)

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

If agreeing to be in the study, patients will be asked to participate in the following:

Patients will have the following tests or procedures (called screening tests) to find out if they can be in the study. Some of these tests and procedures are part of regular cancer care and may be done even if the patient doesn't join the study. Other tests will be done because the patient is in this study. If the patient has had some of these tests or procedures recently, they may not have to be repeated. This will be up to the study doctor.

STUDY PROCEDURES
Screening

• Medical history: This includes questions about medical illnesses, medications,past radiation therapy the patient has received, surgeries, allergies, and family history
  of illnesses.


• Complete physical exam including measuring the patient's vital signs that includes blood pressure, temperature, pulse and respirations. Weight will also be recorded at this time.


• Performance Status Assessment: Patients will be asked some questions to determine how their disease is progressing and how the disease affects the quality of their life.


• Electrocardiogram (ECG): This is a routine test that involves attaching small wires to the patient's arms, legs and chest to read the electrical activity of their heart. This test is considered a standard medical test to assess heart function.


• CT scan or MRI or another tumor assessment to determine the extent of the patient's cancer. These are done as part of the patient's standard care and are not being done
  solely for the purpose of this study.


• Chest X-ray (only if CT scan of chest has not been done)


• DEXA (bone density scan) An x-ray test used to assess bone strength


• MUGA (heart scan) This scan involves the injection of a small amount of radioactive materials into a vein in the patient's arm and will allow the research staff to assess how well the patient's heart pumps blood.


• Blood tests (about 5 teaspoonfuls) for evaluating the patient's general health and to measure the phosphate levels in the patient's blood. A small needle will be inserted into a vein for this test.


• Urine sample (about 2 tablespoons) to assess the patient's kidney function and to check the amount of phosphate and calcium in their urine


• Pregnancy test: A blood test for female patients who are able to become pregnant.

If these tests show that the patient is eligible, they will come to the clinic in the morning of Cycle 1, Day 1.

All the patients in this study will be treated with 400 mg sorafenib (two, 200 mg oral tablets), twice a day on a continuous basis. This is the dose schedule approved by the
FDA for treatment of renal cell cancer. Treatment will follow a 4-week (28 day) schedule, and each 4-week period is known as a cycle. The first time the patient receives sorafenib, the patient will be in the clinic. When the patient leaves the clinic, and for the rest of the time the patient is in the study, they will be given enough sorafenib tablets to take on their own at home until their next scheduled clinic visit.

Patients will be watched to be sure they do not have bad side effects from the sorafenib. If the patient does have bad side effects, their dose of sorafenib may be delayed or lowered by the study doctor at future visits.

While participating in the study, patients will have general safety evaluations such as blood pressure, weight and laboratory tests, every week for the first six weeks of their sorafenib treatment. Then, the patient will have safety evaluations on the first day of Cycles 3 and 4; that is, every 28 days. After Cycle 4, patients will have safety evaluations performed every 3rd Cycle, on the first day of Cycles 7, 10 and 13 or about every three months, for as long as the patient remains on the study.

Patients will have evaluations for phosphate levels in their blood and urine before treatment with sorafenib and at the beginning of Cycles 2, 3 and 4. These tests will allow the research staff to see if phosphate levels in the patient's blood are related to bone density. A blood test related to heart function will be done before treatment with sorafenib and at the beginning of Cycles 3, 5 and 7. This test (BNP) measures a peptide (similar to a protein) in the patient's blood that is associated with how well the patient's heart functions.

In order to find out whether sorafenib may or may not affect bone mineral density, patients will have a bone density test called a DEXA scan before they start treatment with sorafenib. This test will be repeated at the beginning of Cycles 4 and 7. This is a painless procedure commonly used to assess bone strength.

In order to find out if sorafenib has an effect on the patient's heart function, patients will have a heart scan called a MUGA before they start treatment with sorafenib and at the beginning of Cycles 3, 5 and 7. This scan will allow the research staff to asses how well the patient's heart pumps blood.

Prior to the patient's treatment with sorafenib and every eight weeks while taking sorafenib, patients will have a CT scan (special x-rays where a section of the patient's body is scanned), or an MRI (a different type of scan that does not involve x-rays) or another method of tumor assessment to determine the extent of the patient's cancer.

TREATMENT PLAN
The 4-week cycle of treatment with sorafenib will be repeated for as long as the patient does not have serious side effects and their cancer does not get worse.

How long will the Study run?

Patients will be in the study as long as they are not experiencing any drug-related side effects that they cannot tolerate, their cancer has not progressed, and the study remains open.

Sponsor(s): Bayer Healthcare Pharmaceuticals

Study Activation/Registration Date: 04/15/2008

IRB Review and Approval Date: 03/12/2008

Study Type: Treatment

Projected Accrual: The plan is to have up to 50 patients participate from Mayo Clinic.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Michael E. Menefee, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 08/28/2008