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A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

4 novembre 2014 mis à jour par: Hoffmann-La Roche

A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer

This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

124

Phase

  • Phase 2

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

  • Australie
    • Victoria
      • East Bentleigh, Victoria, Australie, VIC 3165
      • Geelong, Victoria, Australie, 3220
  • Belgique
      • Leuven, Belgique, 3000
  • Corée, République de
      • Bundang City, Corée, République de, 463-802
      • Daegu, Corée, République de, 700-712
      • Gyeonggi-do, Corée, République de, 411-769
      • Incheon, Corée, République de, 405-760
      • Seoul, Corée, République de, 138-736
      • Seoul, Corée, République de, 110-744
      • Seoul, Corée, République de, 120-752
      • Seoul, Corée, République de, 135-710
      • Seoul, Corée, République de, 137-807
      • Suwon, Corée, République de
  • Espagne
      • Alicante, Espagne, 3010
      • Barcelona, Espagne, 08035
      • La Coruña, Espagne, 15006
      • Madrid, Espagne, 28046
      • Madrid, Espagne, 28041
      • Madrid, Espagne, 28222
      • Malaga, Espagne, 29010
      • Sevilla, Espagne, 41014
  • France
      • Bayonne, France, 64100
      • Dijon, France, 21079
      • Le Mans, France, 72037
      • Marseille, France, 13273
      • Paris, France, 75674
      • Strasbourg, France, 67091
      • Vandoeuvre-les-nancy, France, 54511
  • Italie
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italie, 33081
    • Lombardia
      • Milano, Lombardia, Italie, 20133
    • Marche
      • Ancona, Marche, Italie, 60121
    • Toscana
      • Lido Di Camaiore, Toscana, Italie, 55043
  • Lituanie
      • Kaunas, Lituanie, 50009
      • Vilnius, Lituanie, 08660
  • Pays-Bas
      • 's Hertogenbosch, Pays-Bas, 5211 RW
      • Amsterdam, Pays-Bas, 1007 MB
      • Eindhoven, Pays-Bas, 5623 EJ
      • Groningen, Pays-Bas, 9713 GZ
      • Heerlen, Pays-Bas, 6419 PC
      • Maastricht, Pays-Bas, 6229 HX
      • Rotterdam, Pays-Bas, 3045 PM
  • Pologne
      • Lodz, Pologne, 91-520
      • Lublin, Pologne, 20-950
      • Otwock, Pologne, 05-400
  • Roumanie
      • Bucuresti, Roumanie, 022328
      • Cluj Napoca, Roumanie, 400015
      • Timisoara, Roumanie, 1900
  • Royaume-Uni
      • Dudley, Royaume-Uni, DY1 2HQ
      • Guildford, Royaume-Uni, GU2 7XX
      • Manchester, Royaume-Uni, M2O 4BX
  • Singapour
      • Singapore, Singapour, 119074
  • Taïwan
      • Changhua, Taïwan, 500
      • Kaohsiung, Taïwan, 00833
      • Tainan, Taïwan, 710
      • Taipei, Taïwan
      • Taipei, Taïwan, 114
      • Taipei, Taïwan, 112

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;
  • advanced (stage IIIb and IV) non-small cell lung cancer;
  • measurable disease;
  • ECOG PS 0-1.

Exclusion Criteria:

  • prior chemotherapy or treatment with another systemic anti-cancer agent;
  • radiotherapy within 4 weeks prior to first dose of study treatment;
  • CNS metastases;
  • other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.

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
Comparateur actif: Bevacizumab, Chemotherapy
Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (*) minute (min) on Day 1 of Cycles 1 through 4 or 6. The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
Médicament: Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Autres noms:
  • Avastin
Médicament: Standard platinum-based chemotherapy
At the discretion of the investigator
Expérimental: Bevacizumab, Erlotinib
Participants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
Médicament: Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Autres noms:
  • Avastin
Médicament: Erlotinib
150 mg, PO, daily
Autres noms:
  • Tarceva

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Disease Progression or Death
Délai: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
PFS
Délai: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Who Died
Délai: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive.
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
OS
Délai: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive.
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
Délai: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Percentage of Participants With Disease Control According to RECIST V 1.0
Délai: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit
Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit

Collaborateurs et enquêteurs

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

Parrainer

Hoffmann-La Roche

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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 janvier 2008

Achèvement primaire (Réel)

1 janvier 2010

Achèvement de l'étude (Réel)

1 janvier 2010

Dates d'inscription aux études

Première soumission

18 septembre 2007

Première soumission répondant aux critères de contrôle qualité

18 septembre 2007

Première publication (Estimation)

19 septembre 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

11 novembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 novembre 2014

Dernière vérification

1 novembre 2014

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BO20571

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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