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Study of Etoposide in Breast Cancer Patients



Study of Etoposide in Breast Cancer Patients

For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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:
Study Type:  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry 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.
Total Enrollment: 33

Location and Contact Information:

National Cancer Institute (NCI) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Clinical  Support Center/NCI 1-888-624-1937


Additional Information:
Study ID Numbers:  990161;  99-C-0161
Study Start Date: August 27, 1999
Record last reviewed: August 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026949

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4. Polyphenon E (Green Tea Extract) and Low-Dose Aspirin in Preventing Cancer in Women at High Risk For Developing Breast Cancer

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