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

3 de março de 2016 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

627

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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).
Medicamento: capecitabina [Xeloda]
1000mg/m2 por via oral nos dias 1-15 de cada ciclo de 3 semanas
Medicamento: Oxaliplatin
As prescribed, in 3 week cycles
Medicamento: Oxaliplatin
As prescribed, in 2 week cycles
Comparador Ativo: 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).
Medicamento: Oxaliplatin
As prescribed, in 3 week cycles
Medicamento: Oxaliplatin
As prescribed, in 2 week cycles
Medicamento: 5 FU
As prescribed, in 2 week cycles
Medicamento: Leucovorin
As prescribed, in 2 week cycles

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression Free Survival
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression Free Survival Based on Independent Review Committee Assessment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2003

Conclusão Primária (Real)

1 de agosto de 2006

Conclusão do estudo (Real)

1 de agosto de 2006

Datas de inscrição no estudo

Enviado pela primeira vez

15 de setembro de 2003

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de setembro de 2003

Primeira postagem (Estimativa)

18 de setembro de 2003

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

1 de abril de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de março de 2016

Última verificação

1 de março de 2016

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NO16967

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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