Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor
2010년 8월 9일 업데이트: Eli Lilly and Company
Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy
The purpose of this study is to help answer:
- Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last
- Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer
연구 개요
연구 유형
중재적
등록 (실제)
41
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Miami, Florida, 미국, 33179
- 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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Illinois
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Evanston, Illinois, 미국, 60201
- 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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Kansas
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Wichita, Kansas, 미국, 67214
- 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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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- 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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Missouri
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Saint Louis, Missouri, 미국, 63110
- 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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Nebraska
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Omaha, Nebraska, 미국, 68114
- 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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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- 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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Tennessee
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Chattanooga, Tennessee, 미국, 37404
- 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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Memphis, Tennessee, 미국, 38120
- 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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Nashville, Tennessee, 미국, 37203
- 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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Texas
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Houston, Texas, 미국, 77060
- 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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Caxias Do Sul, 브라질, 95070560
- 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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Porto Alegre, 브라질, 90430-090
- 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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Santo Andre, 브라질, 09090780
- 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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Bangalore, 인도, 560 029
- 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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Mumbai, 인도, 400016
- 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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Trivandrum, 인도, 695011
- 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:
- You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy.
- You have good kidney, liver, and bone marrow organ function.
- You are fully active or able to carry out light work such as housework or office work.
Exclusion Criteria:
- You have received pemetrexed or gemcitabine in the past for lung cancer
- You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past
- You are unable to take corticosteroid drugs like dexamethasone
- You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study
- You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study
- You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication
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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실험적: Less Than One Year: Pemetrexed
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
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500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
다른 이름들:
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
다른 이름들:
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실험적: Less Than One Year: Pemetrexed + Gemcitabine
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
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500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
다른 이름들:
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실험적: One Year or Greater: Pemetrexed + Carboplatin
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
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500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
다른 이름들:
area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
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실험적: One Year or Greater: Pemetrexed + Gemcitabine
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
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500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
다른 이름들:
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Objective Tumor Response
기간: baseline to time of response (up to 17.5 months)
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Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
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baseline to time of response (up to 17.5 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Survival
기간: baseline to trial termination (17.5 months)
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Overall survival is the number of participants who were alive when the trial was terminated.
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baseline to trial termination (17.5 months)
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Time to Progressive Disease
기간: baseline to measured progressive disease (up to 17.5 months)
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baseline to measured progressive disease (up to 17.5 months)
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Duration of Response
기간: time of response to progressive disease (up to 17.5 months)
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time of response to progressive disease (up to 17.5 months)
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Time to Treatment Failure
기간: baseline to stopping treatment (up to 17.5 months)
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baseline to stopping treatment (up to 17.5 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 9월 1일
기본 완료 (실제)
2008년 6월 1일
연구 완료 (실제)
2009년 4월 1일
연구 등록 날짜
최초 제출
2006년 7월 24일
QC 기준을 충족하는 최초 제출
2006년 7월 24일
처음 게시됨 (추정)
2006년 7월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2010년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2010년 8월 9일
마지막으로 확인됨
2010년 8월 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. .