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Study of Etoposide in Breast Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00026949
First Posted: November 15, 2001
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Official Title: Pharmacokinetics of Etoposide in Patients With Breast Cancer Receiving High-Dose Etoposide

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 33
Study Start Date: August 1999
Estimated Study Completion Date: August 2004
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026949


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00026949     History of Changes
Other Study ID Numbers: 990161
99-C-0161
First Submitted: November 14, 2001
First Posted: November 15, 2001
Last Update Posted: March 4, 2008
Last Verified: August 2004

Keywords provided by National Institutes of Health Clinical Center (CC):
Etoposide
Breast Cancer
Pharmacokinetics

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Etoposide
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action