Multicenter Study Investigating Utilization of Pharmacokinetic(PK)-Guided Docetaxel in Senior Adult Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Rate of Achieving Targeted Area Under the Curve (AUC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Function Assessment of Cancer Therapy (FACT) Surveys (Other)
结局指标
主要结局
Rate of Achieving Targeted Area Under the Curve (AUC)
时间窗: 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.
次要结局
- 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)
- 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)