Phase I Trial of Oral Etoposide in Combination With Celecoxib in Patients With Advanced Malignancies
OBJECTIVES:
- To describe the toxicities of the combination of oral etoposide at 50 mg daily with
escalating doses of celecoxib in patients with advanced malignancies.
- To evaluate the effects of the combination of etoposide and celecoxib on plasma levels
of vascular endothelial growth factor.
OUTLINE: This is a dose-escalation study of celecoxib.
In course 1, patients receive oral etoposide once daily on days 1-35 and oral celecoxib
twice daily on days 8-35. In all subsequent courses, patients receive oral etoposide once
daily and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline, periodically during treatment, and at time of tumor
progression. Samples are analyzed for vascular endothelial growth factor levels by
enzyme-linked immunosorbent assay and stored for future analysis of circulating DNA of
angiogenic biomarkers by polymerase chain reaction assays.
Interventional
Primary Purpose: Treatment
Toxicity
Yes
Przemyslaw W. Twardowski, MD
Study Chair
Beckman Research Institute
United States: Federal Government
01036
NCT00551005
December 2001
February 2012
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