Last updated on September 2011

Dasatinib and Bevacizumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot be Removed by Surgery


Brief description of study

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Bevacizumab may also stop the growth of solid tumors by blocking blood flow to the tumor. Giving dasatinib together with bevacizumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib given together with bevacizumab in treating patients with solid tumor that is metastatic or cannot be removed by surgery.

Detailed Study Description

OBJECTIVES: Primary - To describe the safety and toxicity of the combination of dasatinib and bevacizumab in patients with advanced solid tumors that have progressed on standard therapy. - To find the maximum tolerated dose or recommended phase II dose of this combination. - To describe the biochemical changes in the Src-FAK, Src-PLC-γ, and VEGF signal transduction pathways in tumor and stromal cells in response to treatment. (Group 2) Secondary - To determine, preliminarily, the efficacy of this regimen. - To evaluate correlations between pathway alteration and clinical events. - To evaluate correlations between clinical outcomes and changes in VEGF and other angiogenic cytokines in plasma and circulating endothelial cells. - To evaluate the application of dynamic contrast-enhanced MRI in determining early changes in tumor vascularity during treatment. OUTLINE: This is a dose-escalation study of dasatinib and bevacizumab (group 1) followed by a randomized study (group 2). - Group 1: Patients receive oral dasatinib once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. - Group 2: Patients receive dasatinib and bevacizumab at the maximum tolerated dose determined in group 1. Patients are randomized to 1 of 2 treatment arms. - Arm I: In course 1, patients receive oral dasatinib alone once daily on days 1-28. Beginning in course 2 and for all subsequent courses, patients receive oral dasatinib once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. - Arm II: In course 1, patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Beginning in course 2 and for all subsequent courses, patients receive oral dasatinib once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients in group 2 undergo tumor biopsies and dynamic contrast-enhanced MRI at baseline, after 2 weeks of single-agent therapy, and after ≥ 2 weeks of combined therapy to examine biochemical effects of treatment and to evaluate changes in vascularity and quality of index lesions. Blood samples are also collected from these patients and archived for future studies, including cytokine and invasion marker analysis and circulating endothelial cell analysis. After completion of study therapy, patients are followed for 4 weeks.

Clinical Study Identifier: NCT00792545

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Recruitment Status: Open


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