Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide

Breast Cancer Clinical Trial

Official title:

Multicenter Study Investigating Utilization of Pharmacokinetic(PK)-Guided Docetaxel in Senior Adult Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502864
• Other study ID #: MCC-18118
• Status: Completed
• Phase: Phase 4
• Start date: February 9, 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: September 2020
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 31, 2019
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms

Intervention

Drug:
• Standard of Care: Docetaxel
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.
• Standard of Care: Cyclophosphamide
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.

Other:
• Function Assessment of Cancer Therapy (FACT) Surveys
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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Saladax Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of Patient Profiles and Function Assessment of Cancer Therapy (FACT) Scores	The relationship between PK-guided docetaxel patient PK profiles and the Function Assessment of Cancer Therapy (FACT) Taxane and Breast Cancer scores will be described.	Up to 6 months
Primary	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.	Cycle 4 - Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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).	Baseline and Post Cycle 1
Secondary	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).	Baseline and Post Cycle 1
Secondary	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.	Baseline and Post Cycle 1

External Links

•   Moffitt Cancer Center Clinical Trials website