Kidney Cancer E2810: A Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastasectomy

Full Name

Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastasectomy

Description

Participants will be randomly assigned to receive either pazopanib or a placebo (a pill that looks like pazopanib, but does not contain any active ingredient). Participants will take 4 tablets of pazopanib or 4 tablets of placebo by mouth every day for 13 cycles. A cycle is 28 days long. Participants will be taking the pazopanib or placebo for a total of 52 weeks. In addition, participants will have a CT scan or MRI every 3 months, blood tests every 4 weeks, for cycles 2-13, and will complete quality of life questionnaires.

Eligibility

Inclusion Criteria

o Must be 18 years of age
o Must have confirmed renal cell carcinoma with a clear cell component
o Must be able to swallow pills
o Must be able to receive either CT with IV contrast or MRI with gadolinium
o Must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma