Bevacizumab and Sunitinib in Treating Patients With Solid Tumors

Status:	Archived
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011

A Phase I Study of Bevacizumab in Combination With SU11248

RATIONALE: 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. Sunitinib may stop the growth of
tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and
sunitinib may also stop the growth of tumor cells by blocking blood flow to the tumor.
Giving bevacizumab together with sunitinib may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bevacizumab and
sunitinib in treating patients with solid tumors.

OBJECTIVES:

Primary

- Determine the maximum tolerated dose of bevacizumab in combination with sunitinib
malate (SU11248) in patients with solid tumors.

Secondary

- Evaluate the objective response rate, time to disease progression, and overall survival
of these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and oral sunitinib
malate (SU11248) once daily on days 1-28. Courses repeat every 42 days in the absence of
disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bevacizumab and SU11248 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 10 patients are
treated at the MTD.

After completion of study therapy, patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

We found this trial at

sites

Case Western Reserve Univ

10900 Euclid Ave
Cleveland, Ohio 44106

216-368-2000