Study of Etoposide in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Pharmacokinetics of Etoposide in Patients With Breast Cancer Receiving High-Dose Etoposide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026949
• Other study ID #: 990161
• Secondary ID: 99-C-0161
• Status: Completed
• Phase: N/A
• First received: November 14, 2001
• Last updated: March 3, 2008
• Start date: August 1999
• Est. completion date: August 2004

Study information

• Verified date: August 2004
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hainsworth JD, Greco FA. Etoposide: twenty years later. Ann Oncol. 1995 Apr;6(4):325-41. Review. — View Citation

Herzig RH. High-dose etoposide and marrow transplantation. Cancer. 1991 Jan 1;67(1 Suppl):292-8. Review. — View Citation

Pflüger KH, Hahn M, Holz JB, Schmidt L, Köhl 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. — View Citation