Bevacizumab in Treating Patients With Advanced Solid Tumors
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor .
PURPOSE: This phase I trial is studying how well bevacizumab works in treating patients with advanced solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
Biological: Bevacizumab (Avastin)
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Biomarker and Clinical Evaluation of Bevacizumab (Avastin) to Determine the Role of Nitric Oxide in Anti-VEGF Therapy|
|Study Start Date:||January 2004|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab (Avastin)
Bevacizumab given and then BP checked and skin biopsies obtained.
|Biological: Bevacizumab (Avastin)|
- Determine whether anti-vascular epidermal growth factor (VEGF) treatment comprising bevacizumab causes changes in endothelial cell function, as measured by brachial reactivity, and changes in nitric oxide (NOx), as measured by plasma/urinary/exhaled NOx levels, in patients with advanced solid tumors.
- Determine whether anti-VEGF-related changes in blood pressure correlate with changes in brachial reactivity and NOx levels.
- Evaluate anti-angiogenic effects of bevacizumab in neovascular tissue in the wound angiogenesis model.
- Correlate inhibition of wound angiogenesis with changes in VEGF-receptor 2 phosphorylation status and changes in NOx synthase expression.
- Describe the mean and associated variability of other plasma and urine markers known to be associated with vascular reactivity, endothelial function, and/or tumor angiogenesis.
- Describe, preliminarily, whether these changes correlate with changes in blood pressure, brachial reactivity, NOx levels, or wound angiogenesis.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. After the third dose of bevacizumab, patients may receive additional bevacizumab in combination with chemotherapy in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416637
|Principal Investigator:||Herbert I. Hurwitz, MD||Duke Cancer Institute|