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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Completed; Phase 4

Conditions: Breast Cancer; Breast Cancer Female

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02502864

MCC-18118

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Standard of Care + Surveys

Experimental group

Description:

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.

Treatment:

Other: Function Assessment of Cancer Therapy (FACT) Surveys

Drug: Standard of Care: Docetaxel

Drug: Standard of Care: Cyclophosphamide