- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537029
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clearance (Cl) for Doxorubicin and Cyclophosphamide
Time Frame: 0-48 hours
|
Cyclophosphamide analysis was not possible due to rapid drug degradation
|
0-48 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ronald G Hall, PharmD, Texas Tech University HSC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Doxorubicin
Other Study ID Numbers
- A11-3691
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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