Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
|ClinicalTrials.gov Identifier: NCT01537029|
Recruitment Status : Active, not recruiting
First Posted : February 22, 2012
Last Update Posted : July 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Obesity||Drug: Doxorubicin Drug: Cyclophosphamide||Phase 4|
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)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||February 2019|
|Experimental: Doxorubicin and cyclophosphamide||
Dosed by the patient's treating physician according to local standard of care.
dosage form: IV, Dosage, frequency, and duration: According to local standard of care
- Area under the curve (AUC) for doxorubicin and cyclophosphamide [ Time Frame: 0-72 hours ]
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 ClinicalTrials.gov identifier (NCT number): NCT01537029
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Ronald G Hall, PharmD||Texas Tech University HSC|