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


N/A
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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.

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

990161

NCT ID:

NCT00026949

Start Date:

August 1999

Completion Date:

August 2004

Related Keywords:

  • Breast Cancer
  • Etoposide
  • Breast Cancer
  • Pharmacokinetics
  • Breast Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892