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A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

2016년 3월 3일 업데이트: Hoffmann-La Roche

An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

627

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 그리스
      • Heraklion, 그리스, 71110
      • Thessaloniki, 그리스, 56439
  • 남아프리카
      • Cape Town, 남아프리카, 7500
      • Durban, 남아프리카, 4001
      • Pietermaritzburg, 남아프리카, 3201
      • Port Elizabeth, 남아프리카, 6001
      • Pretoria, 남아프리카, 0001
  • 대만
      • Kueishan, 대만
      • Tainan, 대만, 704
      • Taipei, 대만, 104
  • 대한민국
      • Buchun, 대한민국, 420-021
      • Seoul, 대한민국, 138-736
      • Seoul, 대한민국, 110-744
      • Seoul, 대한민국, 120-752
      • Seoul, 대한민국, 133-792
      • Seoul, 대한민국, 137-040
  • 독일
      • Tübingen, 독일, 72076
  • 미국
    • California
      • Bakersfield, California, 미국, 93309
    • Colorado
      • Colorado Springs, Colorado, 미국, 80903
    • District of Columbia
      • Washington, District of Columbia, 미국, 20007-2197
    • Indiana
      • Terre Haute, Indiana, 미국, 47802
    • Missouri
      • St Louis, Missouri, 미국, 63136
    • Montana
      • Billings, Montana, 미국, 59101
    • New York
      • Nyack, New York, 미국, 10960
    • Texas
      • Dallas, Texas, 미국, 75204
  • 벨기에
      • Bruxelles, 벨기에, 1070
      • Bruxelles, 벨기에, 1000
      • Gent, 벨기에, 9000
      • Kortrijk, 벨기에, 8500
      • Mont-godinne, 벨기에, 5530
  • 세르비아
      • Belgrade, 세르비아, 11000
  • 스페인
      • Barcelona, 스페인, 08907
      • Leganes, 스페인, 28911
      • Madrid, 스페인, 28041
      • Madrid, 스페인, 28035
      • Palma de Mallorca, 스페인, 07014
  • 슬로바키아
      • Bratislava, 슬로바키아, 831 01
  • 슬로베니아
      • Ljubljana, 슬로베니아, 1000
  • 영국
      • Denbigh, 영국, LL18 5UJ
      • Manchester, 영국, M20 4BX
      • Merseyside, 영국, CH63 45Y
      • Preston, 영국, PR2 9HT
  • 이스라엘
      • Beer Sheva, 이스라엘, 8410101
      • Jerusalem, 이스라엘, 91031
      • Kfar Saba, 이스라엘, 44281
      • Petach Tikva, 이스라엘, 49100
      • Ramat-gan, 이스라엘, 52621
      • Rehovot, 이스라엘, 76100
      • Tel Aviv, 이스라엘, 6423906
  • 이탈리아
      • Bergamo, 이탈리아, 24128
      • Cattolica, 이탈리아, 47841
      • Rimini, 이탈리아, 47900
      • Udine, 이탈리아, 33100
  • 캐나다
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 1Z2
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, 캐나다, A1B 3V6
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다, B3H 1V7
    • Ontario
      • London, Ontario, 캐나다, N6A 4L6
      • Oshawa, Ontario, 캐나다, L1G 2B9
      • Ottawa, Ontario, 캐나다, K1H 1C4
      • Saint Catherines, Ontario, 캐나다, L2R 2Z7
      • Thunder Bay, Ontario, 캐나다, P7A 7T1
      • Toronto, Ontario, 캐나다, M5G 2M9
      • Weston, Ontario, 캐나다, M9N 1N8
    • Quebec
      • Laval, Quebec, 캐나다, H7M 3L9
      • Levis, Quebec, 캐나다, G6V 3Z1
      • Montreal, Quebec, 캐나다, H1T 2M4
      • Montreal, Quebec, 캐나다, H2W 1S6
      • Montreal, Quebec, 캐나다, H4J 1C5
      • Quebec City, Quebec, 캐나다, G1R 2J6
    • Saskatchewan
      • Regina, Saskatchewan, 캐나다, S4T 7T1
  • 크로아티아
      • Split, 크로아티아, 21000
      • Zagreb, 크로아티아, 10000
  • 폴란드
      • Bialystok, 폴란드, 15-073
      • Krakow, 폴란드, 31-501
      • Warszawa, 폴란드, 02-781
      • Warszawa, 폴란드, 04-394
  • 푸에르토 리코
      • San Juan, 푸에르토 리코, 00921-3201
  • 프랑스
      • Avignon, 프랑스, 84082
      • Bordeaux, 프랑스, 33076
      • Bordeaux, 프랑스, 33075
      • Chambray-lès-tours, 프랑스, 37044
      • Limoges, 프랑스, 87042
      • Nimes, 프랑스, 30029
      • Pessac, 프랑스, 33604
      • Rouen, 프랑스, 76031
  • 핀란드
      • Tampere, 핀란드, 36280
      • Turku, 핀란드, 20520

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:

  • adult patients >=18 years of age;
  • metastatic colorectal cancer;
  • >=1 target lesion;
  • failed first-line chemotherapy with 5-fluorouracil and irinotecan.

Exclusion Criteria:

  • previous treatment with oxaliplatin;
  • progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
  • >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.

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
실험적: XELOX
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
의약품: 카페시타빈 [Xeloda]
각 3주 주기의 1-15일에 1000mg/m2 po 입찰
의약품: Oxaliplatin
As prescribed, in 3 week cycles
의약품: Oxaliplatin
As prescribed, in 2 week cycles
활성 비교기: FOLFOX-4
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
의약품: Oxaliplatin
As prescribed, in 3 week cycles
의약품: Oxaliplatin
As prescribed, in 2 week cycles
의약품: 5 FU
As prescribed, in 2 week cycles
의약품: Leucovorin
As prescribed, in 2 week cycles

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival
기간: Up to 3 years
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
Up to 3 years

2차 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival Based on Independent Review Committee Assessment
기간: Up to 3 years
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. This PFS evaluation was based on Independent Review Committee Assessment.
Up to 3 years
Progression Free Survival Based on Treatment Analysis- Intent To Treat Population
기간: Up to 3 years
Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.
Up to 3 years
Progression Free Survival Based on Treatment Analysis- Per Population
기간: Up to 3 years
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
Up to 3 years
Best Overall Response, Investigators' Assessments
기간: Up to 3 years
Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks. For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.
Up to 3 years
Best Overall Response, Independent Review Committee Assessment
기간: Up to 3 years
Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD. CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks. This PFS evaluation was based on Independent Review Committee Assessment.
Up to 3 years
Overall Survival
기간: Up to 3 years
Overall survival was measured as the time from the date of randomization to the date of death. Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.
Up to 3 years
Time To Response
기간: Up to 3 years
Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met. CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level. PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.
Up to 3 years
Duration Of Response
기간: Up to 3 years
Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented. CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.
Up to 3 years
Time To Treatment Failure
기간: Up to 3 years
Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.
Up to 3 years
Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
기간: Up to 3 years
Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline. All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system. Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.
Up to 3 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

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

2003년 7월 1일

기본 완료 (실제)

2006년 8월 1일

연구 완료 (실제)

2006년 8월 1일

연구 등록 날짜

최초 제출

2003년 9월 15일

QC 기준을 충족하는 최초 제출

2003년 9월 17일

처음 게시됨 (추정)

2003년 9월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 4월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 3월 3일

마지막으로 확인됨

2016년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NO16967

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. .

대장암에 대한 임상 시험

카페시타빈 [Xeloda]에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Sweden

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다