Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
Pharmacodynamic Study of Sunitinib Malate in Patients With Renal Cell Cancer and Other Advanced Solid Malignancies
This phase I trial is studying the side effects and best way to give sunitinib malate in treating patients with unresectable or metastatic kidney cancer or other advanced solid tumors. Sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. Determine the pharmacodynamic change using functional imaging (3'-deoxy-3'-[18F]
fluorothymidine [FLT]-positron emission tomography [PET]/computed tomography [CT] scans) in
patients with unresectable or metastatic clear cell renal cell carcinoma or other advanced
solid malignancies treated with two different schedules of sunitinib malate.
II. Evaluate the objective response in patients treated with this drug.
SECONDARY OBJECTIVES:
I. Measure the change in plasma vascular endothelial growth factor (VEGF) levels and plasma
hypoxia-inducible factor (HIF)1-alpha levels as a potential mechanism for vascular
endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) failure and rapid
tumor growth following VEGFR TKI withdrawal in these patients.
II. Correlate pharmacokinetics of this drug with response, unexpected toxicity, VEGF levels,
HIF1-alpha levels, and FLT-PET/CT scan changes.
OUTLINE: Patients are assigned to 1 of 2 different treatment schedules of sunitinib malate.
SCHEDULE A: Patients receive sunitinib malate orally (PO) once daily (QD) in weeks 1-4.
Treatment repeats every 6 weeks in the absence of disease progression or unacceptable
toxicity.
SCHEDULE B: Patients receive sunitinib malate PO QD in weeks 1, 2, 4, and 5. Treatment
repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
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