Study of Etoposide in Breast Cancer Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	November 14, 2001
Last Updated Date	March 3, 2008
Start Date ^ICMJE	August 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00026949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Etoposide in Breast Cancer Patients
Official Title ^ICMJE	Pharmacokinetics of Etoposide in Patients With Breast Cancer Receiving High-Dose Etoposide
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.
Detailed Description	Etoposide is a topoisomerase II inhibitor that has a broad range of anticancer activity at conventional doses (100 mg/m(2) daily x 5 days) and is administered in high doses (greater than 1200 mg/m(2)) 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 Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	Herzig RH. High-dose etoposide and marrow transplantation. Cancer. 1991 Jan 1;67(1 Suppl):292-8. Review. Hainsworth JD, Greco FA. Etoposide: twenty years later. Ann Oncol. 1995 Apr;6(4):325-41. Review. Pfluger KH, Hahn M, Holz JB, Schmidt L, Kohl P, Fritsch HW, Jungclas H, Havemann K. Pharmacokinetics of etoposide: correlation of pharmacokinetic parameters with clinical conditions. Cancer Chemother Pharmacol. 1993;31(5):350-6.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	33
Completion Date	August 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	INCLUSION CRITERIA Age greater than or equal to 18 years. Patients with breast cancer who are entered on existing Medicine Branch protocols that include high-dose etoposide. Must be able to provide informed consent.
Gender	Female
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00026949
Responsible Party
Study ID Numbers ^ICMJE	990161, 99-C-0161
Study Sponsor ^ICMJE	National Cancer Institute (NCI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	August 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP