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

3 marca 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

627

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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).
Lek: kapecytabina [Xeloda]
1000 mg/m2 doustnie w dniach 1-15 każdego 3-tygodniowego cyklu
Lek: Oxaliplatin
As prescribed, in 3 week cycles
Lek: Oxaliplatin
As prescribed, in 2 week cycles
Aktywny komparator: 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).
Lek: Oxaliplatin
As prescribed, in 3 week cycles
Lek: Oxaliplatin
As prescribed, in 2 week cycles
Lek: 5 FU
As prescribed, in 2 week cycles
Lek: Leucovorin
As prescribed, in 2 week cycles

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Progression Free Survival
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Progression Free Survival Based on Independent Review Committee Assessment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hoffmann-La Roche

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2003

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2006

Ukończenie studiów (Rzeczywisty)

1 sierpnia 2006

Daty rejestracji na studia

Pierwszy przesłany

15 września 2003

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 września 2003

Pierwszy wysłany (Oszacować)

18 września 2003

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

1 kwietnia 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 marca 2016

Ostatnia weryfikacja

1 marca 2016

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NO16967

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Rak jelita grubego

Badania kliniczne na kapecytabina [Xeloda]

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Warunki

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