Phase 4
Completed N=15
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Source: ClinicalTrials.gov NCT01537029 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Clearance (Cl) for Doxorubicin and Cyclophosphamide — 1.85 L/hr
◆ Published Evidence
Not yet cited
0citations
Impact of obesity on doxorubicin pharmacokinetics in women with breast cancer.
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.
Linked Publications
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Impact of obesity on doxorubicin pharmacokinetics in women with breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clearance (Cl) for Doxorubicin and Cyclophosphamide |
1.85 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01537029) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.