Etoposide and Celecoxib in Patients With Advanced Cancer
RATIONALE: Etoposide and celecoxib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than 1 drug may be an effective treatment for advanced cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with etoposide in treating patients with advanced cancer.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: celecoxib Drug: etoposide Other: immunoenzyme technique Other: laboratory biomarker analysis||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Trial of Oral Etoposide in Combination With Celecoxib in Patients With Advanced Malignancies|
- Maximum tolerated dose
- Time to failure
|Study Start Date:||December 2001|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551005
|Study Chair:||Przemyslaw W. Twardowski, MD||City of Hope Comprehensive Cancer Center|