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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Breast Cancer Obesity
Intervention	Drug: Doxorubicin Drug: Cyclophosphamide
Phase	Phase 4
Sponsor	Texas Tech University Health Sciences Center
Responsible Party	Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier	NCT01537029
First Received	February 16, 2012
Last Updated	January 28, 2014
Last verified	January 2014

Tracking Information[ + expand ][ + ]

First Received Date	February 16, 2012
Last Updated Date	January 28, 2014
Start Date	February 2012
Estimated Primary Completion Date	August 2014
Current Primary Outcome Measures	Area under the curve (AUC) for doxorubicin and cyclophosphamide [Time Frame: 0-72 hours] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Official Title	Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Brief Summary	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.
Detailed Description	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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Condition	Breast Cancer Obesity
Intervention	Drug: Doxorubicin 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
Study Arm (s)	Experimental: Doxorubicin and cyclophosphamide

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	18
Estimated Completion Date	August 2014
Estimated Primary Completion Date	August 2014
Eligibility Criteria	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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Vanessa Tagoe, MA 214-648-4180 mailto:Vanessa.Tagoe@UTSouthwestern.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01537029
Other Study ID Numbers	A11-3691
Has Data Monitoring Committee	Not Provided
Information Provided By	Texas Tech University Health Sciences Center
Study Sponsor	Texas Tech University Health Sciences Center
Collaborators	University of Texas
Investigators	Principal Investigator: Ronald G Hall, PharmD Texas Tech University HSC
Verification Date	January 2014

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