局所進行性または転移性乳癌の高齢患者の治療における Nab-パクリタキセル
65歳以上の局所進行性または転移性乳がん患者におけるナノ粒子アルブミン結合パクリタキセル（アブラキサン）の有効性と忍容性
This phase II trial studies the side effects of nab-paclitaxel in treating older patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
PRIMARY OBJECTIVE:
I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for dose reductions, or delays) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer using a stratification factor based on patient age (at least 5 patients age 75 years or older and no more than 15 patients age 65-70 years).
II. To explore predictors of the need for dose reduction, dose delays, or grade 2-5 toxicity and neuropathy grade 2 or higher based on a cancer-specific geriatric assessment.
OUTLINE:
Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ2
連絡先と場所
研究場所
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-
California
-
Duarte、California、アメリカ、91010
- City of Hope medical
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Lancaster、California、アメリカ、93534
- City of Hope Antelope Valley
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South Pasadena、California、アメリカ、91030
- City of Hope South Pasadena
-
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Ohio
-
Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
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-
参加基準
適格基準
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:
- Locally advanced or metastatic breast cancer
- Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone
- First or second line chemotherapy treatment for metastatic disease
- Karnofsky performance status (KPS) >= 70%
- Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)
- Peripheral neuropathy =< grade 1
- Absolute neutrophil count >= 1,500/mm^3
- Platelets >= 100,000 cells/mm^3
- Hemoglobin (Hb) >= 9.0 g/dl
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal
- Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
- Bilirubin =< 1.5 mg/dl
- Creatinine clearance (calculated or 24 hour) >= 30 ml/min
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients may not be receiving any other investigational agents
- Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
- Known history of allergic reactions to paclitaxel
- Presence of any serious or uncontrolled infection
- Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Treatment (nab-paclitaxel)
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Correlative studies Ancillary studies Given IV
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
時間枠：During and after treatment, up to 2.5 years
|
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 2 or higher toxicities attributed to treatment. |
During and after treatment, up to 2.5 years
|
|
Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
時間枠：On treatment, 28 days per cycle up to 30 months
|
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 3 or higher toxicities attributed to treatment. |
On treatment, 28 days per cycle up to 30 months
|
|
Rate of Participants With a Dose Reduction
時間枠：On treatment, up to 30 months
|
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction. |
On treatment, up to 30 months
|
|
Rate of Participants Requiring Dose Holds
時間枠：While on treatment, up to 30 months
|
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction. |
While on treatment, up to 30 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Response Determined by Response Evaluation Criteria in Solid Tumors
時間枠：Up to 2.5 years
|
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for objective response rate (complete response [CR] + partial response [PR]). RECIST: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. Additionally, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study |
Up to 2.5 years
|
|
Median Progression Free Survival (PFS)
時間枠：From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years
|
PFS will be estimated using the product limit method of Kaplan and Meier. |
From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years
|
|
Cancer-specific Geriatric (CARG) Assessment
時間枠：CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months
|
General linear models and descriptive methods will be used to explore factors as identified by a CARG assessment that may be predictive of toxicity (grade 3 or higher adverse events) or dose reduction. The cancer specific geriatric assessment score includes an evaluation of functional status, co-morbidity, cognition, psychological stats, social functioning and support, and nutritional status. It assesses a patient's age, gender, height, weight, cancer type, dosage, number of chemotherapy agents, hemoglobin, hearing, number of falls in past 6 months, able to take own medicine, whether walking is limited, have physical or emotional problems interfered with social activities and serum creatinine. Scores can range from 0 to to 1, with a higher score indicating higher risk of chemotherapy toxicity. Scores from 0 to 5 are considered low risk, 6 to 9 are considered intermediate risk, and 10 to 19 are considered high risk. |
CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Mina Sedrak、City of Hope Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (推定)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- 11139
- P30CA033572 (米国 NIH グラント/契約)
- 11139 (その他の識別子：City of Hope Comprehensive Cancer Center)
- NCI-2011-03295 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 118196
- 124494
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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。