Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Pharmacodynamic Trial of Sequential Sunitinib With Bevacizumab in Patients With Renal Cell Carcinoma and Other Advanced Solid Malignancies
This phase I trial studies the side effects and the best dose of sunitinib malate when given together with bevacizumab in treating patients with kidney cancer or advanced solid malignancies. 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving sunitinib malate together with bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of sequential sunitinib (sunitinib malate) with
bevacizumab in patients with clear cell kidney cancer.
II. To assess the objective response rate of sequential sunitinib with bevacizumab in
patients with clear cell kidney cancer.
SECONDARY OBJECTIVES:
I. To determine the pharmacodynamic change in standardized uptake values (SUV) peak and
tumor perfusion using fluorine F 18 fluorothymidine positron emission tomography
(FLT-PET)/computed tomography (CT) scans at baseline, during sunitinib exposure, and during
bevacizumab exposure (during sunitinib withdrawal period) in patients with renal cell and
other solid malignancies.
II. To characterize changes in the ratio of free: bound plasma vascular endothelial growth
factor (VEGF) in patients treated with sequential sunitinib with bevacizumab.
OUTLINE: This is a dose-escalation study of sunitinib malate.
Patients receive sunitinib malate orally (PO) on days 1-28 and bevacizumab intravenously
(IV) over 30-90 minutes on day 29. Courses repeat every 6 weeks in the absence of disease
progression or unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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