- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02502864
Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide
September 9, 2020 updated by: H. Lee Moffitt Cancer Center and Research Institute
Multicenter Study Investigating Utilization of Pharmacokinetic(PK)-Guided Docetaxel in Senior Adult Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard of Care + Surveys
Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys.
TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
All participants will receive TC for cycle 1 with subsequent cycles repeated every 3 weeks for a total of 4 cycles.
All initial dosing will be based on actual body weight and height.
Participants will receive up to 4 doses of chemotherapy.
Following their 4th dose of chemotherapy, or the last dose of chemotherapy in which blood level monitoring was performed, participants will be assessed for side effects from the chemotherapy and complete their final written 53 question survey about their quality of life.
|
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.
Other Names:
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 Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Achieving Targeted Area Under the Curve (AUC)
Time Frame: Cycle 4 - Up to 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia
Time Frame: Up to 6 months
|
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
|
Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients
Time Frame: Baseline and Post Cycle 1
|
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
|
Association Between Scores - Instrumental Activities of Daily Living
Time Frame: Baseline and Post Cycle 1
|
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
|
Association Between Scores - Cumulative Illness Rating Scale for Geriatrics
Time Frame: Baseline and Post Cycle 1
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Patient Profiles and Function Assessment of Cancer Therapy (FACT) Scores
Time Frame: Up to 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christine Walko, Pharm.D., H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2016
Primary Completion (Actual)
September 29, 2017
Study Completion (Actual)
January 31, 2019
Study Registration Dates
First Submitted
July 15, 2015
First Submitted That Met QC Criteria
July 16, 2015
First Posted (Estimate)
July 20, 2015
Study Record Updates
Last Update Posted (Actual)
September 11, 2020
Last Update Submitted That Met QC Criteria
September 9, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Docetaxel
- Cyclophosphamide
Other Study ID Numbers
- MCC-18118
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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