Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer
2021年6月26日 更新者：Christina S Baik、University of Washington
A Phase II Study of Weekly Abraxane for Patients With Advanced NSCLC With EGFR Mutations or With Durable Response to an EGFR Tyrosine Kinase Inhibitor Following Front Line Therapy With EGFR Tyrosine Kinase Inhibitors
This research study examines the use of Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) in patients with lung cancer.
Abraxane is a chemotherapy approved to treat patients with breast cancer.
Doctors want to know if Abraxane is safe and effective in treating patients with lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) and epidermal growth factor receptor (EGFR) mutations.
研究概览
详细说明
PRIMARY OBJECTIVES:
I. To evaluate the overall response rate of weekly nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations following front-line therapy with EGFR tyrosine kinase inhibitors (TKI).
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of weekly nab-paclitaxel in patients with advanced NSCLC with EGFR mutations following front-line therapy with an EGFR TKI.
II. To evaluate the time-to-progression and overall survival.
OUTLINE:
Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks and then every 3 months thereafter.
研究类型
介入性
注册 (实际的)
26
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Alaska
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Anchorage、Alaska、美国、99508
- Anchorage Oncology Centre
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Anchorage、Alaska、美国、99508
- Katmai Oncology Group
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Anchorage、Alaska、美国、99508
- Providence Alaska Medical Center
-
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Montana
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Bozeman、Montana、美国、59715
- Bozeman Deaconess Hospital
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Washington
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Kennewick、Washington、美国、99336
- Kadlec Clinic Hematology and Oncology
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Mount Vernon、Washington、美国、98274
- Skagit Valley Hospital
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Port Angeles、Washington、美国、98362
- Olympic Medical Center
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Redmond、Washington、美国、98052
- Group Health Cooperative
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Seattle、Washington、美国、98109
- Fred Hutch/University of Washington Cancer Consortium
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Spokane、Washington、美国、99216
- Spokane Valley Cancer Center-Mission
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Tacoma、Washington、美国、98415
- MultiCare Health System
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Wenatchee、Washington、美国、98801
- Wenatchee Valley Hospital and Clinics
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in tumor deoxyribonucleic acid (DNA) or complete/partial response to first line EGFR tyrosine kinase inhibitors with > or = to 6 months duration of response in patients who do not have a confirmed EGFR mutation
- At least one site of measurable disease as determined by the Investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Progressive disease with radiographic evidence of disease progression per investigator assessment during therapy with an EGFR tyrosine kinase inhibitor in the metastatic setting; patients may continue EGFR inhibitor therapy throughout the screening period until the day prior to nab-paclitaxel treatment initiation
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at the time of informed consent
- Platelet count >= 100,000/uL
- Absolute neutrophil count >= 1,500/uL
- Hemoglobin >= 9 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = < 2.5 times upper limit of normal
- Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
- Bilirubin =< 1.5 mg/dL
- Creatinine =< 1.5 mg/dL
- Women of child-bearing potential (WOCP) and sexually active men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, during treatment and for three months after completing treatment
- Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
- Life expectancy of > 12 weeks
- Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment
Exclusion Criteria:
- Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence
- A single dose of a platinum doublet discontinued due to intolerability without evidence of disease progression is permitted
- Patient is < 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention
- Progressive or symptomatic central nervous system (CNS) metastases; patients with known brain metastasis must have stable disease following treatment with surgery, radiation or both; in addition, they must be off corticosteroids
- Radiotherapy within 7 days of study treatment
- Peripheral neuropathy grade 2 or greater
- Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA) criteria, or myocardial infarction within 6 months
- Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
- Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or cirrhosis
- Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
- Pregnant or breast feeding females
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Treatment (paclitaxel albumin-stabilized nanoparticle formula)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
相关研究
鉴于IV
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
大体时间：Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
|
The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.
|
Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Percentage of Patients Experiencing Toxicity Within a Clinically Significant Category Defined as Neutropenia, Neutropenic Fever, or Neuropathy.
大体时间：Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
|
Toxicity rates will be described as percentage of patient who experienced a Grade 3 or higher clinically significant toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
|
Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
|
|
Overall Survival
大体时间：Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.
|
Will report as median values with their respective 95% confidence intervals will be reported.
Time to event distribution will be estimated using Kaplan-Meier method.
|
Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.
|
|
Overall Percentage of Patients Experiencing Grade 3 or Higher Toxicity.
大体时间：Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
|
Toxicity rates will be described as percentage of patients experiencing Grade 3 or higher toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
|
Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
|
|
Time to Progression.
大体时间：Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
|
Reported as median values with their respective 95% confidence intervals for patients who were assessed.
Time to event distribution will be estimated using the Kaplan-Meier method.
|
Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christina Baik、Fred Hutch/University of Washington Cancer Consortium
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年12月2日
初级完成 (实际的)
2017年10月24日
研究完成
2019年4月29日
研究注册日期
首次提交
2012年6月13日
首先提交符合 QC 标准的
2012年6月13日
首次发布 (估计)
2012年6月15日
研究记录更新
最后更新发布 (实际的)
2021年7月16日
上次提交的符合 QC 标准的更新
2021年6月26日
最后验证
2021年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 7755 (Fred Hutch/University of Washington Cancer Consortium)
- P30CA015704 (美国 NIH 拨款/合同)
- NCI-2012-00865 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- RG1712044 (其他标识符：Fred Hutch/University of Washington Cancer Consortium)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.