ECOG 2805

Principal Investigator:	Seth Cohen, MD
Time frame of study:	Ongoing
Location of Study:	Beth Israel Medical Center St.Luke's-Roosevelt Hospital Center
Contact:	Continuum Cancer Research Program (212) 844-6286

Summary:
Two promising oral anti-cancer therapies, sorafenib and sunitinib, recently have been shown to be effective in patients with advanced renal cell carcinoma (kidney cancer). There is an urgent need for effective adjuvant (postoperative) therapy for kidney cancer, in order to try to reduce the likelihood of recurrence, and the activity of these new agents provides a strong rationale for their testing in this context.

Sorafenib and sunitinib both inhibit molecular processes important in the growth of kidney cancer, including tumor angiogenesis (blood vessel formation). In animal models and several clinical trials, these drugs have been shown to inhibit tumor growth, cause tumor regression, and inhibit metastatic progression (spreading of the cancer).

We propose this trial of sunitinib or sorafenib versus placebo (no medication) in locally advanced kidney cancer. Since sunitinib and sorafenib have shown significant activity in advanced kidney cancer and since there is no known effective adjuvant therapy, a positive result would change clinical practice.

Eligibility and Treatment Plan:
Patients, 18 years and older, with primary-intact renal cell carcinoma, eligible for nephrectomy (surgical removal of all or part of the kidney) with curative intent or resected high grade tumors = 4 cm; no history of distant metastases (spreading of the cancer); no prior anti-cancer therapy for renal cancer.

Patients will begin treatment 4-12 weeks after the nephrectomy for 9 cycles (1 cycle is 6 weeks). Duration of therapy is about a year (54 weeks). There are 3 treatment arms:
Arm A) Patients receive 50 mg adjuvant Sunitinib.
Arm B) Patients receive 400 mg adjuvant Sorafenib.
Arm C) Patients receive placebo (inactive) pills for Sorafinib and Sunitinib.

Benefits and/or Compensation:
Participants receive study-related medication at no charge under the supervision and care of a team of medical professionals. The information gathered from this study may be beneficial to future patients, and sorafenib and/or sunitinib may improve the survival of patients with kidney cancer.