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

3. mars 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

627

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Bruxelles, Belgia, 1070
      • Bruxelles, Belgia, 1000
      • Gent, Belgia, 9000
      • Kortrijk, Belgia, 8500
      • Mont-godinne, Belgia, 5530
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
    • Ontario
      • London, Ontario, Canada, N6A 4L6
      • Oshawa, Ontario, Canada, L1G 2B9
      • Ottawa, Ontario, Canada, K1H 1C4
      • Saint Catherines, Ontario, Canada, L2R 2Z7
      • Thunder Bay, Ontario, Canada, P7A 7T1
      • Toronto, Ontario, Canada, M5G 2M9
      • Weston, Ontario, Canada, M9N 1N8
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
      • Levis, Quebec, Canada, G6V 3Z1
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H2W 1S6
      • Montreal, Quebec, Canada, H4J 1C5
      • Quebec City, Quebec, Canada, G1R 2J6
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
  • Finland
      • Tampere, Finland, 36280
      • Turku, Finland, 20520
  • Forente stater
    • California
      • Bakersfield, California, Forente stater, 93309
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80903
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20007-2197
    • Indiana
      • Terre Haute, Indiana, Forente stater, 47802
    • Missouri
      • St Louis, Missouri, Forente stater, 63136
    • Montana
      • Billings, Montana, Forente stater, 59101
    • New York
      • Nyack, New York, Forente stater, 10960
    • Texas
      • Dallas, Texas, Forente stater, 75204
  • Frankrike
      • Avignon, Frankrike, 84082
      • Bordeaux, Frankrike, 33076
      • Bordeaux, Frankrike, 33075
      • Chambray-lès-tours, Frankrike, 37044
      • Limoges, Frankrike, 87042
      • Nimes, Frankrike, 30029
      • Pessac, Frankrike, 33604
      • Rouen, Frankrike, 76031
  • Hellas
      • Heraklion, Hellas, 71110
      • Thessaloniki, Hellas, 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
  • Italia
      • Bergamo, Italia, 24128
      • Cattolica, Italia, 47841
      • Rimini, Italia, 47900
      • Udine, Italia, 33100
  • Korea, Republikken
      • Buchun, Korea, Republikken, 420-021
      • Seoul, Korea, Republikken, 138-736
      • Seoul, Korea, Republikken, 110-744
      • Seoul, Korea, Republikken, 120-752
      • Seoul, Korea, Republikken, 133-792
      • Seoul, Korea, Republikken, 137-040
  • Kroatia
      • Split, Kroatia, 21000
      • Zagreb, Kroatia, 10000
  • Polen
      • Bialystok, Polen, 15-073
      • Krakow, Polen, 31-501
      • Warszawa, Polen, 02-781
      • Warszawa, Polen, 04-394
  • Puerto Rico
      • San Juan, Puerto Rico, 00921-3201
  • Serbia
      • Belgrade, Serbia, 11000
  • Slovakia
      • Bratislava, Slovakia, 831 01
  • Slovenia
      • Ljubljana, Slovenia, 1000
  • Spania
      • Barcelona, Spania, 08907
      • Leganes, Spania, 28911
      • Madrid, Spania, 28041
      • Madrid, Spania, 28035
      • Palma de Mallorca, Spania, 07014
  • Storbritannia
      • Denbigh, Storbritannia, LL18 5UJ
      • Manchester, Storbritannia, M20 4BX
      • Merseyside, Storbritannia, CH63 45Y
      • Preston, Storbritannia, PR2 9HT
  • Sør-Afrika
      • Cape Town, Sør-Afrika, 7500
      • Durban, Sør-Afrika, 4001
      • Pietermaritzburg, Sør-Afrika, 3201
      • Port Elizabeth, Sør-Afrika, 6001
      • Pretoria, Sør-Afrika, 0001
  • Taiwan
      • Kueishan, Taiwan
      • Tainan, Taiwan, 704
      • Taipei, Taiwan, 104
  • Tyskland
      • Tübingen, Tyskland, 72076

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: capecitabin [Xeloda]
1000mg/m2 po bud på dag 1-15 i hver 3 ukers syklus
Legemiddel: Oxaliplatin
As prescribed, in 3 week cycles
Legemiddel: Oxaliplatin
As prescribed, in 2 week cycles
Aktiv 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).
Legemiddel: Oxaliplatin
As prescribed, in 3 week cycles
Legemiddel: Oxaliplatin
As prescribed, in 2 week cycles
Legemiddel: 5 FU
As prescribed, in 2 week cycles
Legemiddel: Leucovorin
As prescribed, in 2 week cycles

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression Free Survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression Free Survival Based on Independent Review Committee Assessment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2003

Primær fullføring (Faktiske)

1. august 2006

Studiet fullført (Faktiske)

1. august 2006

Datoer for studieregistrering

Først innsendt

15. september 2003

Først innsendt som oppfylte QC-kriteriene

17. september 2003

Først lagt ut (Anslag)

18. september 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. april 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. mars 2016

Sist bekreftet

1. mars 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NO16967

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