국소 진행성 또는 전이성 유방암이 있는 고령 환자 치료에서의 Nab-Paclitaxel
65세 이상의 국소 진행성 또는 전이성 유방암 환자에서 나노입자 알부민 결합 파클리탁셀(아브락산)의 효능 및 내약성
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope medical
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Lancaster, California, 미국, 93534
- City of Hope Antelope Valley
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South Pasadena, California, 미국, 91030
- City of Hope South Pasadena
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Ohio
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Columbus, Ohio, 미국, 43210
- Ohio State University Comprehensive Cancer Center
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
기간: During and after treatment, up to 2.5 years
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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
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Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
기간: On treatment, 28 days per cycle up to 30 months
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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
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Rate of Participants With a Dose Reduction
기간: On treatment, up to 30 months
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Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction. |
On treatment, up to 30 months
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Rate of Participants Requiring Dose Holds
기간: While on treatment, up to 30 months
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Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction. |
While on treatment, up to 30 months
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response Determined by Response Evaluation Criteria in Solid Tumors
기간: Up to 2.5 years
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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
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Median Progression Free Survival (PFS)
기간: 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
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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
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Cancer-specific Geriatric (CARG) Assessment
기간: CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months
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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
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Mina Sedrak, City of Hope Medical Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 11139
- P30CA033572 (미국 NIH 보조금/계약)
- 11139 (기타 식별자: City of Hope Comprehensive Cancer Center)
- NCI-2011-03295 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- 118196
- 124494
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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