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

NCT02502864 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MCC-18118
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Cancer Female

Keywords

senior adult; postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia

  Up to 6 months

• Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients

  Baseline and Post Cycle 1

• Association Between Scores - Instrumental Activities of Daily Living

  Baseline and Post Cycle 1

• Association Between Scores - Cumulative Illness Rating Scale for Geriatrics

  Baseline and Post Cycle 1

Other Outcomes (1)

• Comparison of Patient Profiles and Function Assessment of Cancer Therapy (FACT) Scores

  Up to 6 months

Study Arms (1)

Standard of Care + Surveys

EXPERIMENTAL

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.

Drug: Standard of Care: Docetaxel; Drug: Standard of Care: Cyclophosphamide; Other: Function Assessment of Cancer Therapy (FACT) Surveys

Interventions

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.

Also known as: Taxotere®

Standard of Care + Surveys

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.

Also known as: Cytoxan®

Standard of Care + Surveys

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.

Also known as: Questionnaire

Standard of Care + Surveys

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Saladax Biomedical, Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Cyclophosphamide; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

Recruiting ended early due to slow enrollment. Larger studies may help elucidate a more optimal AUC range for senior adults receiving docetaxel as part of the TC regimen for breast cancer to balance both toxicity and efficacy.

Results Point of Contact

• Title: Christine M. Walko, Pharm.D., BCOP
• Organization: H. Lee Moffitt Cancer Center and Research Institute

christine.walko@moffitt.org

813-745-1519

Study Officials

• Christine Walko, Pharm.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 20, 2015
• Study Start: February 9, 2016
• Primary Completion: September 29, 2017
• Study Completion: January 31, 2019
• Last Updated: September 11, 2020
• Results First Posted: October 18, 2018

Record last verified: 2020-09

Locations

US (1)