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


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Obesity

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Area under the curve (AUC) for doxorubicin and cyclophosphamide

Outcome Time Frame:

0-72 hours

Safety Issue:

No

Principal Investigator

Ronald G Hall, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas Tech University HSC

Authority:

United States: Institutional Review Board

Study ID:

A11-3691

NCT ID:

NCT01537029

Start Date:

February 2012

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • Obesity
  • Breast cancer
  • Pharmacokinetics
  • Obesity
  • Doxorubicin
  • Cyclophosphamide
  • Weight
  • Breast Neoplasms
  • Obesity

Name

Location

University of Texas Southwestern Dallas, Texas  75390