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Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer

2013년 7월 3일 업데이트: Eli Lilly and Company

A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer

Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

49

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 캐나다
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 1Z2
        • 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.
    • Ontario
      • Hamilton, Ontario, 캐나다, L8V 5C2
        • 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.
      • Ottawa, Ontario, 캐나다, K1H 8L6
        • 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.
      • Toronto, Ontario, 캐나다, M5G 2M9
        • 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.

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:

Some of the requirements to be in this study are:

  • Patient must be at least 18 years old.
  • Patient must have been diagnosed with non-small cell lung cancer.
  • Patient must be able to visit the doctor's office once a week.
  • Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.

Exclusion Criteria:

Patients cannot participate in this study for any of the following reasons:

  • Patient has previously had chemotherapy.
  • Patient has previously had thoracic radiation therapy.
  • Patient has received treatment within the last 30 days with a drug that has not received approval by Health Canada for any indication at the time of study entry.
  • Female patient is pregnant or breast-feeding.
  • Patient is unsuitable to participate in the study in the opinion of the investigator.
  • Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

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: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Pemetrexed/Cisplatin/Radiation Phase 1
Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
의약품: Pemetrexed Phase 1
300 mg/m^2 IV, Days 1 and 22; intermediate dose escalation level of 400 mg/m^2 IV; then 500 mg/m^2 IV, repeated every 21 days (q 21 days) x 2 cycles
다른 이름들:
  • 알림타
  • LY231514
의약품: Cisplatin Phase 1

Cohorts 1-3: 25 mg/m^2 IV, Days 1-3 and 22-24 then 75 mg/m^2 IV, q21 days x 2 cycles

Cohort 4 carried into Phase 2: 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles.

절차: Radiation Therapy
Phases 1 and 2: 61-65 Gy in 33-35 fractions
실험적: Pemetrexed/Cisplatin/Radiation Phase 2
Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
절차: Radiation Therapy
Phases 1 and 2: 61-65 Gy in 33-35 fractions
의약품: Pemetrexed Phase 2
Concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22.
다른 이름들:
  • 알림타
  • LY231514
의약품: Cisplatin Phase 2
Phase 2 (Cohort 4 carried over from Phase 1): 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy
기간: Baseline to measured progressive disease (PD; up to 1 year)
Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.
Baseline to measured progressive disease (PD; up to 1 year)
Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year
기간: Baseline to date of death from any cause (up to 1 year)
OS was defined as the time from date of enrollment to death due to any cause.
Baseline to date of death from any cause (up to 1 year)

2차 결과 측정

결과 측정
측정값 설명
기간
Phase 1: Number of Participants With Adverse Events (AE; Toxicity)
기간: Baseline to measured PD (up to 1 year)
A listing of AEs is located in the Reported Adverse Event module.
Baseline to measured PD (up to 1 year)
Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years
기간: Baseline and 2 years and 3 years
OS was defined as the time from date of enrollment to death due to any cause.
Baseline and 2 years and 3 years
Phase 2: Time to Progressive Disease (PD)
기간: Baseline to measured PD (up to 3 years)
Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation.
Baseline to measured PD (up to 3 years)
Phase 2: Percentage of Participants With Progression Free Survival (PFS)
기간: Baseline and 1 year and 2 years and 3 years
The percentage of participants not known to have died as of the data cut-off date or last contact and who did not have PD.
Baseline and 1 year and 2 years and 3 years
Progression Free Survival (PFS)
기간: Baseline to measured PD (up to 36 months)
PFS was defined as the period from study entry until PD, death, or date of last contact. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).
Baseline to measured PD (up to 36 months)
Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)
기간: Baseline to measured PD (up to 3 years)
Response using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants with measurable disease * 100, where objective responders are those participants who have met criteria either for CR or PR.
Baseline to measured PD (up to 3 years)
Phase 2: Site of Progressive Disease (PD)
기간: Baseline to measured PD (up to 3 years)
Summarized participants with local (progression within the sites of initial disease)/regional (disease progression adjacent to but not within the site of initial disease at the start of treatment), distant (disease progression that is blood borne to other parts of the body, including outside the chest or involving the contralateral lung), and local + distant sites of disease. Objective PD is defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions.
Baseline to measured PD (up to 3 years)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eli Lilly and Company

수사관

  • 연구 책임자: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST), Eli Lilly and Company

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

2005년 12월 1일

기본 완료 (실제)

2010년 8월 1일

연구 완료 (실제)

2012년 9월 1일

연구 등록 날짜

최초 제출

2007년 9월 12일

QC 기준을 충족하는 최초 제출

2007년 9월 12일

처음 게시됨 (추정)

2007년 9월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 7월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 7월 3일

마지막으로 확인됨

2013년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 10259
  • H3E-CA-JMHU (기타 식별자: Eli Lilly and Company)

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. .

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Pemetrexed Phase 1에 대한 임상 시험

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