Bevacizumab and Ixabepilone in Treating Patients With Advanced Kidney Cancer
| Status: | Archived |
|---|---|
| Conditions: | Cancer, Cancer, Kidney Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2008 |
A Phase II Study of Bevacizumab in Combination With Ixabepilone in Subjects With Advanced Renal Cell Carcinoma.
RATIONALE: 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 tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such
as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Giving bevacizumab together with ixabepilone
may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with
ixabepilone works in treating patients with advanced kidney cancer.
OBJECTIVES:
Primary
- Determine the objective response rate in patients with advanced renal cell carcinoma
treated with bevacizumab and ixabepilone.
Secondary
- Determine progression-free survival of these patients.
- Characterize the toxicity of bevacizumab and ixabepilone in these patients.
- Determine changes in biomarkers (i.e., tumor tissue biopsy and blood-based proteins,
circulating endothelial cells, and tumor endothelial markers) and correlate with
clinical outcomes in these patients.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 and ixabepilone IV over
1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline, after every 2 courses, and after
completion of treatment to correlate changes in biomarkers with clinical outcomes.
Patients undergo biopsies and blood sample collection periodically for biomarker analysis.
Blood samples are analyzed for protein profiling (e.g., VEGF-A, VEGFR-2, VEGFR-3, and βFGF)
by ELISA; tumor endothelial markers (e.g., TEM7s, TEM8s, CD137s, CD276s, and Apelin) by
ELISA; and circulating endothelial cells (e.g., CD31, CD146, CD31, and CD133) by flow
cytometry. Tumor biopsy samples are analyzed for microvessel density, VEGFR-2, VEGFR-3,
HIF1-a, and PDGFR-b levels, and VEGF independent pathway by IHC.
After completion of study treatment, patients are followed every 3 months.
We found this trial at
1
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National Cancer Institute (NCI) The National Cancer Institute (NCI) is part of the National Institutes...
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