Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-27 @ 9:39 AM
Study NCT ID:
NCT00551005
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2007-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etoposide and Celecoxib in Patients With Advanced Cancer
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Phase I Trial of Oral Etoposide in Combination With Celecoxib in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |
| CHNMC-01036 | None | None | View | |
| CDR0000570381 | REGISTRY | NCI PDQ | View |