Phase I Trial of Oral Etoposide in Combination With Celecoxib in Patients With Advanced Malignancies
- 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.
Primary Purpose: Treatment
Przemyslaw W. Twardowski, MD
Beckman Research Institute
United States: Federal Government