Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Mean Area Under the Curve Over 24 Hours (AUC24)
研究概览
简要总结
RATIONALE: Gathering information from patients of different ages receiving paclitaxel albumin-stabilized nanoparticle formulation for metastatic breast cancer may help doctors understand how the age of the patient changes the way the drug works.
PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients of different ages with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine age-related changes in the pharmacokinetics (pK) of weekly paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in patients with metastatic breast cancer.
- To determine age-related changes in the pharmacodynamics (toxicity) of nab-paclitaxel in these patients.
Secondary
- To determine response and time to progression in these patients.
- To explore predictors of pK parameters in these patients.
- To explore predictors of the need for dose reduction, dose delays, or grade 3 or 4 toxicity in these patients.
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
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Diagnosis of metastatic breast cancer
- •Any estrogen receptor, progesterone receptor, or HER-2/neu status allowed as long as the patient will receive paclitaxel albumin-stabilized nanoparticle formulation alone
- •First- or second-line chemotherapy treatment for metastatic disease planned
排除标准
- •Untreated CNS metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •WBC ≥ 3,000/mm³
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9.0 g/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastases are present in the absence of liver metastases)
- •Bilirubin ≤ 1.5 mg/dL
- •Peripheral neuropathy ≤ grade 1
- •Creatinine clearance ≥ 30 mL/min (calculated or 24-hour)
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Not pregnant or nursing
- •No known history of allergic reactions to paclitaxel
- •No serious or uncontrolled infection
- •Ability to understand and the willingness to sign a written informed consent document
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No ≥ grade 2 toxicity from prior therapy (other than alopecia)
- •No taxane for adjuvant therapy or metastatic disease within the past 12 months
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
研究组 & 干预措施
nab-paclitaxel
干预措施: cognitive assessment (Procedure)
nab-paclitaxel
干预措施: study of socioeconomic and demographic variables (Other)
nab-paclitaxel
干预措施: psychosocial assessment and care (Procedure)
nab-paclitaxel
干预措施: physiologic testing (Other)
nab-paclitaxel
干预措施: questionnaire administration (Other)
nab-paclitaxel
干预措施: pharmacological study (Other)
nab-paclitaxel
干预措施: paclitaxel albumin-stabilized nanoparticle formulation (Drug)
结局指标
主要结局
Mean Area Under the Curve Over 24 Hours (AUC24)
时间窗: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment
Mean of area under the curve over 24 hours (AUC24) reported as well as linear regression of AUC24 by age and chemotherapy toxicity risk score. Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19: patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type
Mean Clearance (CL)
时间窗: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment
Mean CL reported as well as regression results of CL by age and chemotherapy toxicity risk score. Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19: patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type
次要结局
- Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score(Up to 2.5 years)
- Median Event-free Survival (EFS) in Months(From the date treatment begins until the first date on which recurrence, progression or death due to any cause, assessed up to 3.5 years)
- Best Response(Assessed after every 2 cycles of therapy until progression, up to 2.5 years)
- Number of Participants Requiring Dose Reductions(At the completion of treatment, up to 2.5 years)
- Number of Participants With a Dose Omission(At the completion of treatment, up to 2.5 years)
- Percent of Participants With a Grade 3 Toxicity(At the completion of treatment, up to 2.5 years)