Current Research: Medical Oncology

E2805 -- Adjuvant Sunitinib vs Sorafenib vs Placebo for Resected Renal Cell Carcinoma

The purpose of this study is to demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients randomly assigned to adjuvant sunitinib (Arm A) or sorafenib (Arm B) versus placebo (Arm C) after radical or partial nephrectomy.

We hope to determine if either sunitinib (Sutent) or sorafenib (Nexavar®) can prevent recurrence of kidney cancer and to compare the effects of the Sunitinib and the Sorafenib with placebo on kidney cancer to see which is better. It is not known whether the benefits of taking either sunitinib or sorafenib will outweigh the risks. Sorafenib and sunitinib are drugs that have been approved by the FDA for use in advanced kidney cancer.

Eligibility

You may be eligible for this trial if:

• Pre-op: You must have primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent.
• It has been approximately 3-10 weeks since surgery (patients must begin protocol treatment 4-12 weeks post-surgery)
• Tumors ≥ 4 cm AND/OR macroscopic fully resectable nodes AND/OR surgically resectable renal vein thrombus AND/OR surgically resectable inferior vena caval thrombus by radiologic criteria to be clinically ≥pT1bNany (resectable) M0 disease.
• You do not have a history of distant metastases
• No prior anti-cancer therapy is permitted in either the adjuvant or neoadjuvant setting.
• You must not be pregnant or breastfeeding
• Known HIV diagnosis is excluded

Trial Sponsor

• Eastern Cooperative Oncology Group (ECOG)

Project Begin Date

• Mar 2007

Tentative Project End Date

• Aug 2011

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .