NCT01243359

Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies

Phase I Pharmacodynamic Trial of Sequential Sunitinib With Bevacizumab in Patients With Renal Cell Carcinoma and Other Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Clear Cell Renal Cell Carcinoma
• Recurrent Renal Cell Cancer
• Stage I Renal Cell Cancer
• Stage II Renal Cell Cancer
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	sunitinib malate	Given PO
BIOLOGICAL	bevacizumab	Given IV
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	fluorine F 18 fluorothymidine	Undergo FLT PET/CT
PROCEDURE	positron emission tomography	Undergo FLT PET/CT
PROCEDURE	computed tomography	Undergo FLT PET/CT

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-02-01
• First posted: 2010-11-18
• Last updated: 2014-04-02

Locations

2 sites across 1 country: United States