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

3 marzo 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

627

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Bruxelles, Belgio, 1070
      • Bruxelles, Belgio, 1000
      • Gent, Belgio, 9000
      • Kortrijk, Belgio, 8500
      • Mont-godinne, Belgio, 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
  • Corea, Repubblica di
      • Buchun, Corea, Repubblica di, 420-021
      • Seoul, Corea, Repubblica di, 138-736
      • Seoul, Corea, Repubblica di, 110-744
      • Seoul, Corea, Repubblica di, 120-752
      • Seoul, Corea, Repubblica di, 133-792
      • Seoul, Corea, Repubblica di, 137-040
  • Croazia
      • Split, Croazia, 21000
      • Zagreb, Croazia, 10000
  • Finlandia
      • Tampere, Finlandia, 36280
      • Turku, Finlandia, 20520
  • Francia
      • Avignon, Francia, 84082
      • Bordeaux, Francia, 33076
      • Bordeaux, Francia, 33075
      • Chambray-lès-tours, Francia, 37044
      • Limoges, Francia, 87042
      • Nimes, Francia, 30029
      • Pessac, Francia, 33604
      • Rouen, Francia, 76031
  • Germania
      • Tübingen, Germania, 72076
  • Grecia
      • Heraklion, Grecia, 71110
      • Thessaloniki, Grecia, 56439
  • Israele
      • Beer Sheva, Israele, 8410101
      • Jerusalem, Israele, 91031
      • Kfar Saba, Israele, 44281
      • Petach Tikva, Israele, 49100
      • Ramat-gan, Israele, 52621
      • Rehovot, Israele, 76100
      • Tel Aviv, Israele, 6423906
  • Italia
      • Bergamo, Italia, 24128
      • Cattolica, Italia, 47841
      • Rimini, Italia, 47900
      • Udine, Italia, 33100
  • Polonia
      • Bialystok, Polonia, 15-073
      • Krakow, Polonia, 31-501
      • Warszawa, Polonia, 02-781
      • Warszawa, Polonia, 04-394
  • Porto Rico
      • San Juan, Porto Rico, 00921-3201
  • Regno Unito
      • Denbigh, Regno Unito, LL18 5UJ
      • Manchester, Regno Unito, M20 4BX
      • Merseyside, Regno Unito, CH63 45Y
      • Preston, Regno Unito, PR2 9HT
  • Serbia
      • Belgrade, Serbia, 11000
  • Slovacchia
      • Bratislava, Slovacchia, 831 01
  • Slovenia
      • Ljubljana, Slovenia, 1000
  • Spagna
      • Barcelona, Spagna, 08907
      • Leganes, Spagna, 28911
      • Madrid, Spagna, 28041
      • Madrid, Spagna, 28035
      • Palma de Mallorca, Spagna, 07014
  • Stati Uniti
    • California
      • Bakersfield, California, Stati Uniti, 93309
    • Colorado
      • Colorado Springs, Colorado, Stati Uniti, 80903
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20007-2197
    • Indiana
      • Terre Haute, Indiana, Stati Uniti, 47802
    • Missouri
      • St Louis, Missouri, Stati Uniti, 63136
    • Montana
      • Billings, Montana, Stati Uniti, 59101
    • New York
      • Nyack, New York, Stati Uniti, 10960
    • Texas
      • Dallas, Texas, Stati Uniti, 75204
  • Sud Africa
      • Cape Town, Sud Africa, 7500
      • Durban, Sud Africa, 4001
      • Pietermaritzburg, Sud Africa, 3201
      • Port Elizabeth, Sud Africa, 6001
      • Pretoria, Sud Africa, 0001
  • Taiwan
      • Kueishan, Taiwan
      • Tainan, Taiwan, 704
      • Taipei, Taiwan, 104

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Droga: capecitabina [Xeloda]
1000mg/m2 po bid nei giorni 1-15 di ogni ciclo di 3 settimane
Droga: Oxaliplatin
As prescribed, in 3 week cycles
Droga: Oxaliplatin
As prescribed, in 2 week cycles
Comparatore attivo: 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).
Droga: Oxaliplatin
As prescribed, in 3 week cycles
Droga: Oxaliplatin
As prescribed, in 2 week cycles
Droga: 5 FU
As prescribed, in 2 week cycles
Droga: Leucovorin
As prescribed, in 2 week cycles

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival Based on Independent Review Committee Assessment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2003

Completamento primario (Effettivo)

1 agosto 2006

Completamento dello studio (Effettivo)

1 agosto 2006

Date di iscrizione allo studio

Primo inviato

15 settembre 2003

Primo inviato che soddisfa i criteri di controllo qualità

17 settembre 2003

Primo Inserito (Stima)

18 settembre 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 marzo 2016

Ultimo verificato

1 marzo 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NO16967

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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