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

Primary Purpose

Breast Cancer, Obesity

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Doxorubicin

Cyclophosphamide

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Breast cancer, Pharmacokinetics, Obesity, Doxorubicin, Cyclophosphamide, Weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Texas Southwestern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Doxorubicin and cyclophosphamide

Arm Description

Outcomes

Primary Outcome Measures

Clearance (Cl) for Doxorubicin and Cyclophosphamide

Cyclophosphamide analysis was not possible due to rapid drug degradation

Secondary Outcome Measures

Full Information

NCT ID

NCT01537029

First Posted

February 16, 2012

Last Updated

July 24, 2018

Sponsor

Texas Tech University Health Sciences Center

Collaborators

University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT01537029

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

February 2012 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Texas Tech University Health Sciences Center

Collaborators

University of Texas

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Obesity

Keywords

Breast cancer, Pharmacokinetics, Obesity, Doxorubicin, Cyclophosphamide, Weight

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doxorubicin and cyclophosphamide

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Description

Dosed by the patient's treating physician according to local standard of care.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

dosage form: IV, Dosage, frequency, and duration: According to local standard of care

Primary Outcome Measure Information:

Title

Clearance (Cl) for Doxorubicin and Cyclophosphamide

Description

Cyclophosphamide analysis was not possible due to rapid drug degradation

Time Frame

0-48 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald G Hall, PharmD

Organizational Affiliation

Texas Tech University HSC

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Southwestern

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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