Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026949
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-11-14
Brief Title:
Study of Etoposide in Breast Cancer Patients
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pharmacokinetics of Etoposide in Patients With Breast Cancer Receiving High-Dose Etoposide
Status:
COMPLETED
Status Verified Date:
2004-08
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:
This study will examine how the body handles etoposide a drug used to treat breast cancer The knowledge gained may lead to more effective use of the drug with fewer side effects in the future
Breast cancer patients who are receiving etoposide as part of their treatment may participate in this study Patients will have 18 blood samples about a teaspoon or less each drawn over a 72-hour period during and after their infusion of etoposide The initial blood samples cannot be taken from the same intravenous line small tube placed in a vein used to deliver the etoposide so a second line may have to be placed temporarily to obtain these samples
Breast cancer patients who are receiving etoposide as part of their treatment may participate in this study Patients will have 18 blood samples about a teaspoon or less each drawn over a 72-hour period during and after their infusion of etoposide The initial blood samples cannot be taken from the same intravenous line small tube placed in a vein used to deliver the etoposide so a second line may have to be placed temporarily to obtain these samples
Detailed Description:
Etoposide is a topoisomerase II inhibitor that has a broad range of anticancer activity at conventional doses 100 mgm2 daily x 5 days and is administered in high doses greater than 1200 mgm2 as a component of pre-transplant myeloablative chemotherapy regimens Etoposide pharmacokinetics are linear over a 30-fold dose range but disposition is highly variable Etoposide is highly protein bound 95 to albumin but protein binding and therefore free drug concentrations vary widely in cancer patients Etoposide is eliminated by metabolism and renal excretion which may also contribute to the variability The pharmacokinetics of etoposide will be studied in patients receiving high-dose etoposide as part of their pre-transplant preparative regimen and pharmacokinetic parameters generated from pharmacokinetic modeling will be correlated with clinical and laboratory characteristics and toxicity in order to develop more rational dosing methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0161 | None | None | None |