IRB Number:

06-004586

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

The purpose of this study is to see if either Sunitinib or Sorafenib can prevent recurrence of a patient's kidney cancer and to compare the effects (both good and bad) of the Sunitinib and the Sorafenib with placebo (pills that look like the study drugs, but are not active or do not contain the drug) on the patient and their kidney cancer to see which is better.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with kidney cancer that has just been removed, or is about to be removed, and is thought to be at high risk of coming back

What is Involved With this Study?

If patients agree to be in the study, they will be asked to participate in the following:
Patients will take two tablets of Sorafenib or placebo twice a day for six weeks and four capsules of Sunitinib or placebo once a day for four weeks followed by a two-week break. This regimen is called a cycle.

Patients will follow nine cycles of this treatment for about one year. During this time they will have routine physical exams, blood tests, CT scans, heart scans and bone scans to make sure they are doing well with the study medicine and to make sure their kidney cancer has not come back. After they have completed one year of treatment, patients will stop taking the study medicines but will continue to be followed for possible side effects from the treatment and to detect possible recurrence of their cancer.

Before starting the study, patients will have the following exams, tests, and procedures to find out if they can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if the patient does not take part in the study. If the patient has had some of them recently, they may not need to be done again. This will be up to the study doctor.

- Physical exam
- Blood tests
- Pregnancy test, if woman able to become pregnant
- Urinalysis
- MUGA (Multi Gated Acquisition) scan - This type of scan involves injecting a small amount of radioactive material to see how the patient's heart is working.
- CT scan of the chest, abdomen and pelvis with IV contrast or an equivalent scan and/or MRI scans
- Blood pressure checked
- Electrocardiogram (EKG) done

During the study, patients will have the following test and procedures done:
- A physical exam by their study doctor every six weeks (every cycle of treatment).
- Blood pressure monitoring every week for the first six weeks and then every six weeks (every cycle of treatment)
- Laboratory tests every six weeks (every cycle of treatment) to make sure that bone marrow, remaining kidney, liver, and other vital organs remain healthy. These tests measure the levels of various enzymes, proteins and other compounds found in the patient's blood.
- A pill count with their study coordinator every six weeks (every cycle of treatment).
- Pregnancy test, if woman able to become pregnant
- CT and/or MRI scan every four and one half months (every three cycles of treatment).
- A MUGA scan will be done at three, six and 12 months, at the end of treatment, and at any time a patient develops certain symptoms which warrant a MUGA.

Some of these tests would be done even if the patient does not take part in the study.

Patients will be put in one of three groups by chance (as in the flip of a coin). Neither the patient nor their study doctor can choose the group they will be in. Patients will have an equal chance of being placed in any of the three study groups.

Whichever study group the patient is placed in, they will take one of the following combinations:
- Sorafenib and placebo capsules, OR
- Sunitinib and placebo tablets, OR
- A combination of placebo capsules and tablets

The drug used in this study is considered investigational, which means it has either not been approved by the U.S. Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug in this research study.

How long will the Study run?

Patients will get study medicine for 54 weeks (about one year). They will continue to be followed for an additional nine years for total study duration of 10 years to look at
the long-term effects of the study.

Sponsor(s): Eastern Cooperative Oncology Group (ECOG)

Study Activation/Registration Date: 10/01/2007

IRB Review and Approval Date: 08/22/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 1,344 patients participate from multiple medical centers.

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

Principal Investigator: Patrick A. Burch, 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: 08/29/2008