Skip to main content
OpenTrials
Completed

NCT Number: NCT02502864

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care: Docetaxel

Drug

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: Taxotere®

Standard of Care: Cyclophosphamide

Drug

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: Cytoxan®

Function Assessment of Cancer Therapy (FACT) Surveys

Other

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: Questionnaire

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Saladax Biomedical, Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jul 20, 2015
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.