Phase I Trial of Oral Cyclophosphamide in Combination With Celecoxib in Patients With Advanced Malignancies
- To describe the toxicities of oral cyclophosphamide when administered with escalating
doses of celecoxib in patients with advanced malignancies.
- To evaluate the effects of this regimen on plasma levels of vascular endothelial growth
OUTLINE: This is a dose-escalation study of celecoxib.
In the first course, patients receive oral cyclophosphamide once daily on days 1-35 and oral
celecoxib twice daily on days 8-35. In all subsequent courses, patients receive oral
cyclophosphamide 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 and stored
for future analysis of circulating DNA of angiogenic biomarkers.
After completion of study therapy, patients are followed periodically.
Primary Purpose: Treatment
Przemyslaw W. Twardowski, MD
Beckman Research Institute
United States: Federal Government