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

3 марта 2016 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

627

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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).
Лекарство: капецитабин [Кселода]
1000 мг/м2 перорально 2 раза в день с 1 по 15 день каждого 3-недельного цикла
Лекарство: Oxaliplatin
As prescribed, in 3 week cycles
Лекарство: Oxaliplatin
As prescribed, in 2 week cycles
Активный компаратор: 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).
Лекарство: Oxaliplatin
As prescribed, in 3 week cycles
Лекарство: Oxaliplatin
As prescribed, in 2 week cycles
Лекарство: 5 FU
As prescribed, in 2 week cycles
Лекарство: Leucovorin
As prescribed, in 2 week cycles

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Progression Free Survival
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Progression Free Survival Based on Independent Review Committee Assessment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Hoffmann-La Roche

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 июля 2003 г.

Первичное завершение (Действительный)

1 августа 2006 г.

Завершение исследования (Действительный)

1 августа 2006 г.

Даты регистрации исследования

Первый отправленный

15 сентября 2003 г.

Впервые представлено, что соответствует критериям контроля качества

17 сентября 2003 г.

Первый опубликованный (Оценивать)

18 сентября 2003 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

1 апреля 2016 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 марта 2016 г.

Последняя проверка

1 марта 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • NO16967

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования капецитабин [Кселода]

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