Study of Etoposide in Breast Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

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 Type: Observational
• Enrollment: 33

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Cancer Institute (NCI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Herzig RH. High-dose etoposide and marrow transplantation. Cancer. 1991 Jan 1;67(1 Suppl):292-8. doi: 10.1002/1097-0142(19910101)67:1+3.0.co;2-7.
• Hainsworth JD, Greco FA. Etoposide: twenty years later. Ann Oncol. 1995 Apr;6(4):325-41. doi: 10.1093/oxfordjournals.annonc.a059180.
• 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. doi: 10.1007/BF00686147.

Study record dates

Study Major Dates

• Study Start: August 1, 1999
• Study Completion: August 1, 2004

Study Registration Dates

• First Submitted: November 14, 2001
• First Submitted That Met QC Criteria: November 14, 2001
• First Posted (Estimate): November 15, 2001

Study Record Updates

• Last Update Posted (Estimate): March 4, 2008
• Last Update Submitted That Met QC Criteria: March 3, 2008
• Last Verified: August 1, 2004

More Information

Terms related to this study

• Keywords: Breast Cancer; Pharmacokinetics; Etoposide
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 990161; 99-C-0161