Impact of Body weight on the pharmacokinetic analysis of Doxorubicin and Cyclophosphamide in Breast Cancer Patients

Study ID
STU 062011-056

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
J Susan Armstrong
214-645-4673
susan.armstrong@utsouthwestern.edu

Principal Investigator
Ronald Hall

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 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 line 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 peripheral intravenous line 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.

noTe: Treatment with Doxurubicin and Cyclophosphamide is required to participate in this pharmacokinetic analysis study.

Participants will be compensated for participating in this study. each participant will receive $150.00 as gift cards at the end of the study ($50 for study day 1, $50 for the 12-24 hour blood draw, and $50 for the 24-72 hour blood draw). Participants who stop taking part in this study or are withdrawn by the research team will receive payment for only the blood draws you have completed. Compensation is for the long wait time on day 1 and their travel and time associated with the 12-24 hour and 24-72 hour blood draws.

Participant Eligibility

Females, age 18 years of age or older, of all racial and ethnic origins who 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.