A PHASE 3, RANDOMIZED STUDY OF SU011248 VERSUS INTERFERON-a AS FIRST-LINE SYSTEMIC THERAPY FOR PATIENTS WITH METASTATIC RENAL CELL CARCINOMA

The purpose of this study is to determine the efficacy and safety of single-agent SU011248 compared to IFN as a first-line therapy in patients with metastatic RCC.  Patients with histological confirmed metastatic RCC with an ECOG performance status of 0 or 1 who have adequate vital organ function will be enrolled in this clinical trial.

Patients randomized to the SUO11248 arm will receive SUO11248 at 50mg/day for 4 weeks followed by a 2-week rest period to form a 6-week treatment cycle.  Patients randomized to IFN will receive IFN given as a subcutaneous injection on three non-consecutive days per week.  Patients will receive 3 million units per dose during the first week, 6 MU per dose the second week, and 9 MU per dose thereafter.

INCLUSION CRITERIA:

• Metastatic Renal Cell Cancer with a component of clear cell histology;
  nephrectomy not required.
• Measurable disease
• ECOG performance status 0 or 1
• Normal MUGA Scan

EXCLUSION CRITERIA:

• Prior systemic therapy
• History of Brain metastases
• Unstable Cardiac arrhythmias
• Any of the following within the 12 months prior to study drug: MI, unstable angina, coronary/peripheral artery bypass graft, CHF, CVA, TIA or Pulmonary embolism
• History of hemorrhage < 4 weeks of starting therapy