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

3 mars 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

627

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Médicament: capécitabine [Xeloda]
1 000 mg/m2 po bid les jours 1 à 15 de chaque cycle de 3 semaines
Médicament: Oxaliplatin
As prescribed, in 3 week cycles
Médicament: Oxaliplatin
As prescribed, in 2 week cycles
Comparateur actif: 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).
Médicament: Oxaliplatin
As prescribed, in 3 week cycles
Médicament: Oxaliplatin
As prescribed, in 2 week cycles
Médicament: 5 FU
As prescribed, in 2 week cycles
Médicament: Leucovorin
As prescribed, in 2 week cycles

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression Free Survival
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Progression Free Survival Based on Independent Review Committee Assessment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2003

Achèvement primaire (Réel)

1 août 2006

Achèvement de l'étude (Réel)

1 août 2006

Dates d'inscription aux études

Première soumission

15 septembre 2003

Première soumission répondant aux critères de contrôle qualité

17 septembre 2003

Première publication (Estimation)

18 septembre 2003

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 avril 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 mars 2016

Dernière vérification

1 mars 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NO16967

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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