Impact of Body Weight on Pharmacokinetic Analysis of Doxorubicin + Cyclophosphamide in Breast Cancer

NCT01542203 | Withdrawn

• 1 other identifier: STU 062011-056
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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 cyclophosphamide (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 Doxorubicin and Cyclophosphamide in order to participate in this pharmacokinetic analysis study.

Conditions

Breast Cancer

Keywords

doxorubicin; cyclophosphamide; Breast Cancer; BMI

Study Arms (1)

Breast Cancer, Various BMIs

18 female breast cancer patients 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

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 cyclophosphamide (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:
• Alter doxorubicin concentrations: carbamazepine, cyclosporine, fosphenytoin, paclitaxel, phenytoin, sorafenib, valspodar, verapamil
• Alter cyclophosphamide concentrations: cyclosporine, nevirapine, ondansetron
• All other drugs will be reviewed during screening of the patient

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Texas Tech University Health Sciences Center: collaborator

Study Sites (1)

UTSouthwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: March 2, 2012
• Study Start: June 25, 2012
• Primary Completion: September 15, 2016
• Study Completion: June 5, 2017
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

US (1)