Spots Global Cancer Trial Database for A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

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Trial Identification

Brief Title: A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

Official Title: A Phase II, Single Arm, Prospective Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

Study ID: NCT00480935

Conditions

Renal Cell Carcinoma

Interventions

Sunitinib Malate (Sutent)

Study Description

Brief Summary: Study Hypothesis: Patients with local renal cell carcinoma who are treated neoadjuvantly with Sutent may show a radiologic response to the study drug (Sutent). The study is looking at the neoadjuvant (pre-surgery) administration of Sutent in patients with localized kidney cancer. The purpose of this research is also to evaluate both the safety and effectiveness of Sutent in this patient population.

Detailed Description: Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week rest period. The dosage may change during the cycle due to possible drug toxicities. The nephrectomy will then take place following a one-week washout period. After surgery, patients will have follow-up visits at 6 weeks and 3 months. Patients will be followed for 3 years after completions to assess late toxicities, time to progression and progression-free survival.