Clinical trial NCT02502864: Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide
Official title: Multicenter Study Investigating Utilization of Pharmacokinetic(PK)-Guided Docetaxel in Senior Adult Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Breast Cancer Female
Keywords: senior adult
postmenopausal
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Saladax Biomedical, Inc.
First posted: 2015-07-20
Enrollment: 9
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard TC (docetaxel 75 mg/m\^2 and cyclophosphamide 600mg/m\^2)
* Age \>/= 65 years (Senior adult focused study given increased risk for toxicity)
* Participants must be female
* Eastern Cooperative Oncology Group (ECOG) performance status \<2
* Must have normal organ and marrow function
* No pre-existing neuropathy grade \> 1 per the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
* Be postmenopausal (defined as amenorrheic for at least 12 months)
* Must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and Good Clinical Practice (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.

Exclusion Criteria:

* Have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements
* Have psychiatric illness that would limit compliance with study requirements
* Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide
* Have known seropositivity for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or syphilis. Does not require serologic confirmation as a study procedure.
* Not willing to follow protocol requirements or to give informed consent

Primary outcomes:
measure: Rate of Achieving Targeted Area Under the Curve (AUC)
timeFrame: Cycle 4 - Up to 6 months
Secondary outcomes:
measure: Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia
timeFrame: Up to 6 months
measure: Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients
timeFrame: Baseline and Post Cycle 1
measure: Association Between Scores - Instrumental Activities of Daily Living
timeFrame: Baseline and Post Cycle 1
measure: Association Between Scores - Cumulative Illness Rating Scale for Geriatrics
timeFrame: Baseline and Post Cycle 1
Other outcomes:
measure: Comparison of Patient Profiles and Function Assessment of Cancer Therapy (FACT) Scores
timeFrame: Up to 6 months
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Christine Walko, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: