Ignite Creation Date:
2025-12-18 @ 7:02 AM
Ignite Modification Date:
2025-12-18 @ 7:02 AM
Study NCT ID:
NCT00734890
Status:
None
Last Update Posted:
2012-03-16 00:00:00
First Post:
2008-08-13 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vandetanib and Bevacizumab in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: