Lung Cancer Clinical Trial
Official title:
Phase I Study of Vandetanib (ZD 6474) and Bevacizumab Combination Therapy Evaluating the VEGF and EGF Signal Transduction Pathways in Adults With Solid Tumors and Lymphomas
RATIONALE: Vandetanib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth
in different ways. Some block the ability of cancer cells to grow and spread. Others find
cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and
vandetanib may also stop the growth of cancer cells by blocking blood flow to the cancer.
Giving vandetanib together with bevacizumab may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and
bevacizumab in treating patients with advanced solid tumors or lymphoma.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose, safety, and toxicity of vandetanib and
bevacizumab in patients with advanced solid tumors or lymphoma.
Secondary
- Characterize the pharmacokinetic profile of this regimen in these patients.
- Measure changes in VEGF and other angiogenic cytokines in plasma samples from these
patients.
- Determine the biochemical changes in the EGF signal transduction pathways in tumor
biopsy samples from these patients.
- Determine the anti-angiogenic effects of this regimen in tumor biopsy samples from
these patients.
- Evaluate the application of dynamic contrast-enhanced MRI to determine early changes in
tumor vascular permeability during treatment.
- Evaluate the effects of this regimen on circulating endothelial progenitors and mature
circulating endothelial cells in these patients.
OUTLINE: Patients receive oral vandetanib once daily on days 1-21 and bevacizumab IV over
30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression
or unacceptable toxicity.
Patients undergo blood sample collection periodically for correlative laboratory studies,
including pharmacokinetic, biomarker (VEGF and other angiogenic cytokines), and circulating
endothelial cell analysis. Patients may also undergo optional tumor biopsies for additional
correlative laboratory studies.
;
Primary Purpose: Treatment
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