Vandetanib and Bevacizumab in Treating Patients With Advanced Solid Tumors or Lymphoma
|ClinicalTrials.gov Identifier: NCT00734890|
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : March 16, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Lymphoma Lymphoproliferative Disorder Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Biological: bevacizumab Drug: vandetanib Other: laboratory biomarker analysis Other: pharmacological study||Phase 1|
- Determine the maximum tolerated dose, safety, and toxicity of vandetanib and bevacizumab in patients with advanced solid tumors or lymphoma.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|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|
|Study Start Date :||March 2008|
|Primary Completion Date :||June 2010|
|Study Completion Date :||February 2011|
- Maximum tolerated dose
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734890
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Shivaani Kummar, MD||NCI - Medical Oncology Branch|