ECOG 1808: A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features

Summary:
Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.
This randomized phase II clinical trial studies the effect of giving sunitinib malate with or without gemcitabine hydrochloride. The goal is to determine how well these drugs work in the treatment of patients with advanced kidney cancer that cannot be surgically removed.

Eligibility and Treatment Plan:
• Histologically confirmed renal cell carcinoma (of any subtype) containing any sarcomatoid features
• At least 18 years old
• No collecting duct or medullary cancer
• No central nervous system disease
• More than 2 weeks since last radiation treatment

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