NCT01537029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 breast-cancer

Timeline
Completed

Started Feb 2012

Typical duration for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 22, 2018

Completed
Last Updated

August 22, 2018

Status Verified

July 1, 2018

Enrollment Period

4.8 years

First QC Date

February 16, 2012

Results QC Date

July 24, 2018

Last Update Submit

July 24, 2018

Conditions

Breast CancerObesity

Keywords

Breast cancerPharmacokineticsObesityDoxorubicinCyclophosphamideWeight

Outcome Measures

Primary Outcomes (1)

  • Clearance (Cl) for Doxorubicin and Cyclophosphamide

    Cyclophosphamide analysis was not possible due to rapid drug degradation

    0-48 hours

Study Arms (1)

Doxorubicin and cyclophosphamide

EXPERIMENTAL
Drug: DoxorubicinDrug: Cyclophosphamide

Interventions

DoxorubicinDRUG

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

Doxorubicin and cyclophosphamide
CyclophosphamideDRUG

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

Doxorubicin and cyclophosphamide

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • Hall RG 2nd, Liu S, Pai MP, Putnam WC, Subramaniyan I, Kallem R, Haley B. Impact of obesity on doxorubicin pharmacokinetics in women with breast cancer. J Oncol Pharm Pract. 2025 Mar 13:10781552251326045. doi: 10.1177/10781552251326045. Online ahead of print.

    PMID: 40080880DERIVED

MeSH Terms

Conditions

Breast NeoplasmsObesityBody Weight

Interventions

DoxorubicinCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
Ronald Hall
Organization
TTUHSC
ronald.hall@ttuhsc.edu
2143589009

Study Officials

  • Ronald G Hall, PharmD

    Texas Tech University HSC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 22, 2018

Results First Posted

August 22, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)