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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. Identifier: NCT01537029
Recruitment Status : Recruiting
First Posted : February 22, 2012
Last Update Posted : December 6, 2017
University of Texas
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Obesity Drug: Doxorubicin Drug: Cyclophosphamide Phase 4

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  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Study Start Date : February 2012
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Doxorubicin and cyclophosphamide 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

Primary Outcome Measures :
  1. Area under the curve (AUC) for doxorubicin and cyclophosphamide [ Time Frame: 0-72 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01537029

Contact: Vanessa Tagoe, MA 214-648-4180

United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Todd Morgan    214-648-4180   
Principal Investigator: Ronald G Hall, PharmD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center
University of Texas
Principal Investigator: Ronald G Hall, PharmD Texas Tech University HSC

Responsible Party: Texas Tech University Health Sciences Center Identifier: NCT01537029     History of Changes
Other Study ID Numbers: A11-3691
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Texas Tech University Health Sciences Center:
Breast cancer

Additional relevant MeSH terms:
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors