Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating
patients with previously untreated metastatic kidney cancer.
PRIMARY OBJECTIVES:
I. To determine the feasibility of intermittent sunitinib therapy in patients with metastatic
renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
I. To determine the clinical outcome (response rate and overall progression-free survival) in
metastatic renal cell carcinoma patients treated with intermittent sunitinib therapy.
II. To evaluate the toxicity of intermittent sunitinib therapy in patients with metastatic
renal cell carcinoma.
III. To assess the feasibility of detecting circulating tumor cells (CTCs) in RCC patients
and investigate the association between the VEGF -634 genotype and the occurrence of
hypertension in sunitinib-treated RCC patients.
OUTLINE:
Patients receive oral sunitinib malate once daily on days 1-28. Sunitinib dosing schedule may
be changed to 14 days on followed by 7 days off, and repeated for a 6-week cycle, at the
discretion of the treating physician for toxicity purposes. Cycles will be defined as 6 week
intervals regardless of dosing interruptions. All patients will be treated for 4 cycles in
the absence of unacceptable toxicity or RECIST-defined progressive disease.
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