Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
2011년 4월 8일 업데이트: Eli Lilly and Company
Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.
연구 개요
연구 유형
중재적
등록 (실제)
211
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Beijing, 중국, 101149
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Guang Zhou, 중국, 510080
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hang Zhou, 중국, 310022
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nan Jing, 중국, 210002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shanghai, 중국, 200433
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tianjin, 중국, 300060
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wu Han, 중국, 430030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to curative surgery or radiotherapy
- At least one prior chemotherapy for palliative therapy
- Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status assessment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Exclusion Criteria:
- Concurrent administration of any other tumor therapy
- Pregnant or breast feeding
- Serious concomitant disorders
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 도세탁셀
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75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment
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실험적: 페메트렉시드
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500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Survival
기간: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)
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Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause.
Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
An amendment allowed for the collection of overall survival on an additional 43 survival events.
At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable.
The median and 95% CIs are now reported.
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baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Tumor Response
기간: baseline to measured tumor response (up to 24 months after study enrollment)
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Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria.
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baseline to measured tumor response (up to 24 months after study enrollment)
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Progression-Free Survival (PFS)
기간: baseline to measured progressive disease (up to 24 months after study enrollment)
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Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause.
For patients who were alive and had not progressed, PFS was censored at the last contact.
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baseline to measured progressive disease (up to 24 months after study enrollment)
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Duration of Response
기간: time of response to progressive disease (up to 24 months)
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Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause.
For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact.
Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm.
Available data are presented as "Number of Patients with Disease Progression".
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time of response to progressive disease (up to 24 months)
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Pharmacology Toxicity
기간: first dose of study drug up to 24 months
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Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported.
The worst grade event per cycle is reported.
Grades range from 0 (none) to 5 (death).
Grade 3 events are severe and Grade 4 events are life-threatening.
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first dose of study drug up to 24 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Wu YL, Sun Y, Zhou CC, Zhang L, Yu SY, Ma SL, Han LL, Zhang XQ, Orlando M. Survival without common toxicity criteria grade 3/4 toxicity following second-line treatment with pemetrexed for nonsquamous non-small cell lung cancer in Chinese patients. Chin Med J (Engl). 2013;126(24):4624-8.
- Sun Y, Wu YL, Zhou CC, Zhang L, Zhang L, Liu XY, Yu SY, Jiang GL, Li K, Qin SK, Ma SL, Han L, Quinlivan M, Orlando M, Zhang XQ. Second-line pemetrexed versus docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer: a randomized, open-label study. Lung Cancer. 2013 Feb;79(2):143-50. doi: 10.1016/j.lungcan.2012.10.015. Epub 2012 Nov 20.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 10월 1일
기본 완료 (실제)
2008년 12월 1일
연구 완료 (실제)
2010년 6월 1일
연구 등록 날짜
최초 제출
2006년 10월 19일
QC 기준을 충족하는 최초 제출
2006년 10월 19일
처음 게시됨 (추정)
2006년 10월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 4월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 4월 8일
마지막으로 확인됨
2011년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
비소세포폐암에 대한 임상 시험
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Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
pemetrexed에 대한 임상 시험
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Virginia Commonwealth UniversityEli Lilly and Company; Bayer종료됨
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University of KansasMerck Sharp & Dohme LLC완전한
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Emory UniversityOSI Pharmaceuticals빼는
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Henan Cancer HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.알려지지 않은
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Asan Medical CenterKorea Research Institute of Bioscience & Biotechnology완전한
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Third Military Medical University알려지지 않은
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Avistone Biotechnology Co., Ltd.아직 모집하지 않음
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Sun Yat-sen UniversityWu Jieping Medical Foundation모병