The purpose of this study is to adjust the amount of docetaxel participants receive based on the level of docetaxel measured in their blood. This method of dose adjustment is called pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of docetaxel using this method will lessen the side effects associated with docetaxel in cancer treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Pharmacokinetic(PK)-guided docetaxel. Cycle 1: 75 mg/m\^2, intravenously (IV) on Day 1 for 60 minutes. Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle.
Cycle 1: 600 mg/m\^2, via IV on Day 1 for 30 minutes. The cyclophosphamide dose will not be changed unless dictated by toxicity.
Participants will complete the FACT-Taxane and FACT-Breast quality of life assessment written surveys at baseline, during each chemotherapy cycle, and 3-5 weeks following the last cycle in which PK monitoring was performed.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rate of Achieving Targeted Area Under the Curve (AUC)
Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg\*hr/L) within 4 cycles of therapy in patients \> 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.
Time frame: Cycle 4 - Up to 6 months
Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia
The incidence of grade 3 and 4 neutropenia and febrile neutropenia in cycles following PK adjustment (cycles 2-4) will be compared with cycle 1 and historical non-PK guided therapy using the Wilcoxon-Rank sum assessment.
Time frame: Up to 6 months
Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients
The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score will be reported as ordinal data (low, intermediate-low, intermediate-high, or high risk).
Time frame: Baseline and Post Cycle 1
Association Between Scores - Instrumental Activities of Daily Living
The Instrumental Activities of Daily Living (IADL) total score will be reported as binomial data (greater or less than 26 based on how it is incorporated into the CRASH score).
Time frame: Baseline and Post Cycle 1
Association Between Scores - Cumulative Illness Rating Scale for Geriatrics
The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) will be reported as discrete data out of a possible score of 65. The Wilcoxon-Rank sum and Chi-squared tests will be used as appropriate.
Time frame: Baseline and Post Cycle 1
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