Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide|
- Area under the curve (AUC) for doxorubicin and cyclophosphamide [ Time Frame: 0-72 hours ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
|Experimental: Doxorubicin and cyclophosphamide||
Dosed by the patient's treating physician according to local standard of care.Drug: Cyclophosphamide
dosage form: IV, Dosage, frequency, and duration: According to local standard of care
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537029
|Contact: Vanessa Tagoe, MA||214-648-4180||mailto:Vanessa.Tagoe@UTSouthwestern.edu|
|United States, Texas|
|University of Texas Southwestern||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Todd Morgan 214-648-4180 firstname.lastname@example.org|
|Principal Investigator: Ronald G Hall, PharmD|
|Principal Investigator:||Ronald G Hall, PharmD||Texas Tech University HSC|