Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
18 Years
N/A
Female
Breast Cancer, Obesity
Trial Information
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This
study is designed to measure drug concentrations in the blood of 18 female breast cancer
patients who require doxorubicin (30 minute infusion) and cylcophosphamide (30 minute
infusion) as part of standard medical care. Up to a total of 40 adult female participants
will be consented for the study at the cancer center. Eighteen of these participants are
needed to complete the study. The others will likely be screen failures. The participants
will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just
prior to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h
after the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The
intravenous catheter will be removed when the participant is discharged from the cancer
center on day 1. The participant will be asked to return to the cancer center at 12-24 and
24-72 hours to have the final 2 blood draws conducted.
The participants must be treated with Doxurubicin and Cyclophosphamide in order to
participate in this pharmacokinetic analysis study.
Inclusion Criteria:
- Females, age 18 years of age or older, of all racial and ethnic origins that are
scheduled to receive the first cycle of a single intravenous dose of doxorubicin (30
minute infusion) and cylcophosphamide (30 minute infusion) as part of standard
medical care for breast cancer. English and/or Spanish speaking participants are
eligible to participate.
Exclusion Criteria:
- Pregnant or nursing or unwilling to use a reliable contraception method during the
study. The effects of doxorubicin and cyclophosphamide on pregnancy are unknown. In
addition, the metabolic changes that accompany pregnancy may alter the
concentration-time profile of doxorubicin or cyclophosphamide, so that the pregnancy
and post-partum state would be a confounding variable.
- Participants unwilling to comply with study procedures.
- CrCl < 10 ml/min
- Participants requiring peritoneal or hemodialysis
- Serum bilirubin > 1.19 mg/dL
- Receipt of the following drugs that: a) Alter doxorubicin concentrations:
carbamazepine, cyclosporine, fosphenytoin, paclitaxel, phenytoin, sorafenib,
valspodar, verapamil; b) Alter cyclophosphamide concentrations: cyclosporine,
nevirapine, ondansetron; c) All other drugs will be reviewed during screening of the
patient
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Area under the curve (AUC) for doxorubicin and cyclophosphamide
Outcome Time Frame:
0-72 hours
Safety Issue:
No
Principal Investigator
Ronald G Hall, PharmD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Texas Tech University HSC
Authority:
United States: Institutional Review Board
Study ID:
A11-3691
NCT ID:
NCT01537029
Start Date:
February 2012
Completion Date:
June 2014
Related Keywords:
- Breast Cancer
- Obesity
- Breast cancer
- Pharmacokinetics
- Obesity
- Doxorubicin
- Cyclophosphamide
- Weight
- Breast Neoplasms
- Obesity
Name | Location |
|---|---|
| University of Texas Southwestern | Dallas, Texas 75390 |
