Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide

Completed · Phase 4

Conditions studied: Breast Cancer, Obesity

In brief

To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than participants who weigh less. Restated, the area under the drug-concentration time profile, also known as the AUC, in participants will decrease as participant weight increases.

Key facts

Study ID

NCT01537029

Run by

Texas Tech University Health Sciences Center

People needed

15

Starts

2012-02-01

Expected to finish

2016-12-01

Last updated by the study team

2018-08-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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