Study of Etoposide in Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Breast Cancer focused on measuring Etoposide, Breast Cancer, Pharmacokinetics
Eligibility 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.
Sites / Locations
- National Cancer Institute (NCI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00026949
First Posted
November 14, 2001
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00026949
Brief Title
Study of Etoposide in Breast Cancer Patients
Official Title
Pharmacokinetics of Etoposide in Patients With Breast Cancer Receiving High-Dose Etoposide
Study Type
Observational
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Etoposide, Breast Cancer, Pharmacokinetics
7. Study Design
Enrollment
33 (false)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1984830
Citation
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.
Results Reference
background
PubMed Identifier
7619747
Citation
Hainsworth JD, Greco FA. Etoposide: twenty years later. Ann Oncol. 1995 Apr;6(4):325-41. doi: 10.1093/oxfordjournals.annonc.a059180.
Results Reference
background
PubMed Identifier
8431968
Citation
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.
Results Reference
background
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Study of Etoposide in Breast Cancer Patients
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