Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer
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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Alaska
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Anchorage、Alaska、アメリカ、99508
- Anchorage Oncology Centre
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Anchorage、Alaska、アメリカ、99508
- Katmai Oncology Group
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Anchorage、Alaska、アメリカ、99508
- Providence Alaska Medical Center
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Montana
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Bozeman、Montana、アメリカ、59715
- Bozeman Deaconess Hospital
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Washington
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Kennewick、Washington、アメリカ、99336
- Kadlec Clinic Hematology and Oncology
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Mount Vernon、Washington、アメリカ、98274
- Skagit Valley Hospital
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Port Angeles、Washington、アメリカ、98362
- Olympic Medical Center
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Redmond、Washington、アメリカ、98052
- Group Health Cooperative
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Seattle、Washington、アメリカ、98109
- Fred Hutch/University of Washington Cancer Consortium
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Spokane、Washington、アメリカ、99216
- Spokane Valley Cancer Center-Mission
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Tacoma、Washington、アメリカ、98415
- MultiCare Health System
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Wenatchee、Washington、アメリカ、98801
- Wenatchee Valley Hospital and Clinics
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
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相関研究
与えられた IV
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
時間枠: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.
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The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall Percentage of Patients Experiencing Toxicity Within a Clinically Significant Category Defined as Neutropenia, Neutropenic Fever, or Neuropathy.
時間枠: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.
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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.
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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.
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Overall Survival
時間枠: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.
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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.
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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.
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Overall Percentage of Patients Experiencing Grade 3 or Higher Toxicity.
時間枠: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.
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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.
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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.
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Time to Progression.
時間枠: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.
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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.
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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.
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Christina Baik、Fred Hutch/University of Washington Cancer Consortium
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 7755 (Fred Hutch/University of Washington Cancer Consortium)
- P30CA015704 (米国 NIH グラント/契約)
- NCI-2012-00865 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))
- RG1712044 (その他の識別子:Fred Hutch/University of Washington Cancer Consortium)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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