We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01537029
Recruitment Status : Recruiting
First Posted : February 22, 2012
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

February 16, 2012
February 22, 2012
December 6, 2017
February 2012
February 2018   (Final data collection date for primary outcome measure)
Area under the curve (AUC) for doxorubicin and cyclophosphamide [ Time Frame: 0-72 hours ]
Same as current
Complete list of historical versions of study NCT01537029 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Breast Cancer
  • Obesity
  • 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
Experimental: Doxorubicin and cyclophosphamide
Interventions:
  • Drug: Doxorubicin
  • Drug: Cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
February 2019
February 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Vanessa Tagoe, MA 214-648-4180 mailto:Vanessa.Tagoe@UTSouthwestern.edu
United States
 
 
NCT01537029
A11-3691
No
Not Provided
Plan to Share IPD: No
Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
University of Texas
Principal Investigator: Ronald G Hall, PharmD Texas Tech University HSC
Texas Tech University Health Sciences Center
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP