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

Status:	Archived
Conditions:	Lung Cancer, Cancer, Cancer, Kidney Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	October 2010

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

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth and 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 cells to grow and spread. Others find tumor cells and help kill them or
carry tumor-killing substances to them. Giving sunitinib maleate together with bevacizumab
may kill more tumor cells.

PURPOSE: This phase I clinical trial is studying the side effects of sunitinib malate and
how well it works when given together with bevacizumab in treating patients with metastatic
kidney cancer and other advanced solid tumors.

OBJECTIVES:

Primary

- To evaluate the safety and tolerability of sequential sunitinib malate and bevacizumab
in patients with clear cell kidney cancer.

- To assess the objective response rate of sequential sunitinib malate and bevacizumab in
patients with clear cell kidney cancer.

Secondary

- To determine the pharmacodynamic change in SUVpeak and tumor perfusion using
3'-deoxy-3'-[18F]- fluorothymidine (^18F-FLT) PET/CT scans at baseline, during
sunitinib exposure, and during bevacizumab exposure (during sunitinib withdrawal
period) in patients with renal cell and other solid malignancies.

- To characterize changes in the ratio of free-bound plasma VEGF in patients treated with
sequential sunitinib with bevacizumab.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate on days 1-28 and bevacizumab IV over 30-90 minutes on
day 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable
toxicity.

Plasma samples are collected at baseline and periodically during study for pharmacokinetics
and VEGF analyses by ELISA.

Some patients receive 13'-deoxy-3'-[^18F]- fluorothymidine IV and undergo PET/CT scans at
baseline, on week 4 (between days 24-28), and week 6 (between days 38-42).

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study, including at least
6 patients with renal cell cancer (RCC) in each dose cohort and 15 patients with RCC at the
recommended phase II dose of sunitinib maleate.

We found this trial at

sites

University of Wisconsin-Madison, Department of Dermatology

Madison, Wisconsin 53715

from

Madison, WI