- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01196078
A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
29 juin 2015 mis à jour par: Hoffmann-La Roche
A Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemo-naive, Advanced, Non-Small-Cell Lung Cancer Patients Aged 70 Years or Older in Taiwan
This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer.
Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles).
The anticipated time on study treatment is until disease progression.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
114
Phase
- Phase 4
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
-
-
-
Taipei, Taïwan
-
-
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
70 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Adult patients, >=70 years of age
- Non-small cell lung cancer
- Naive to prior chemotherapy or specific immunotherapy
- Presence of at least 1 measurable lesion
Exclusion Criteria:
- Active non-controlled infection or disease
- CNS metastases
- Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)
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: 1
|
150 mg, orally once a day for up to 6 cycles of 21 days each
|
Comparateur actif: 2
|
60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
Délai: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
|
CR was defined as disappearance of all target lesions.
PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders.
Participants with tumour assessment unevaluable were viewed as non-responders.
|
Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of Participants Achieving Disease Control
Délai: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
|
Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria.
Participants with tumor assessment unevaluable were viewed as uncontrolled.
|
Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
|
Duration of Response Among Participants Who Achieved Either a CR or PR
Délai: Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up
|
Duration of response was defined similarly for complete and partial responders.
Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death.
Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.
|
Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up
|
Percentage of Participants With Disease Progression
Délai: Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
|
Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
|
Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
|
Time to Disease Progression
Délai: Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
|
Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.
|
Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
|
Overall Survival: Percentage of Participants With an Progressive Disease or Death
Délai: Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
|
Overall survival was defined as the time from the date of randomization to the date of death.
Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization.
Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
|
Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
|
Overall Survival: Time to Event
Délai: Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
|
Overall survival was defined as the time from the date of randomization to the date of death.
Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization.
Overall median time to event was assessed for the population that experienced an event.
|
Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
|
Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire
Délai: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer.
Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life.
PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24.
LCS scores ranged from 0-36.
For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'.
For other subscales and questionnaires, the higher score represented 'Worsened'.
Missing data were replaced by the valid post-baseline assessment before.
The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.
|
Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
Changes in Quality of Life as Measured by the FACT Questionnaire
Délai: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer.
Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life.
PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24.
LCS scores ranged from 0-36.
For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'.
For other subscales and questionnaires, the higher score represented 'Worsened'.
Missing data were replaced by the valid post-baseline assessment before.
For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.
|
Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change
Délai: Baseline and End of study
|
The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer.
For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'.
For other subscales and questionnaires, the higher score represented Worsened'.
For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.
|
Baseline and End of study
|
Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire
Délai: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much).
The LCS total score is the sum of the scores from the 7 items.
For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'.
Missing data were replaced by the valid post-baseline assessment before.
The change of FACT-L subscore was the change from baseline to endpoint.
The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).
|
Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
|
Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change
Délai: Baseline and End of study
|
The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition).
The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much).
For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'.
For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.
|
Baseline and End of study
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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 février 2007
Achèvement primaire (Réel)
1 décembre 2010
Achèvement de l'étude (Réel)
1 décembre 2010
Dates d'inscription aux études
Première soumission
3 septembre 2010
Première soumission répondant aux critères de contrôle qualité
3 septembre 2010
Première publication (Estimation)
8 septembre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 juillet 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 juin 2015
Dernière vérification
1 juin 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de protéine kinase
- Chlorhydrate d'erlotinib
- Vinorelbine
Autres numéros d'identification d'étude
- ML20322
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 .
Essais cliniques sur Cancer du poumon non à petites cellules
-
University of Alabama at BirminghamRésiliéLymphome anaplasique à grandes cellules | Lymphome T angio-immunoblastique | Lymphomes T périphériques | Leucémie à cellules T de l'adulte | Lymphome T adulte | Lymphome T périphérique Non précisé | T/Null Cell Systemic Type | Lymphome cutané à cellules T avec maladie nodale/viscéraleÉtats-Unis
-
Adelphi Values LLCBlueprint Medicines CorporationComplétéLeucémie mastocytaire (MCL) | Mastocytose systémique agressive (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | Mastocytose systémique fumante (SSM) | Mastocytose systémique indolente (ISM) Sous-groupe ISM entièrement recrutéÉtats-Unis
-
National Cancer Institute (NCI)ComplétéCarcinome différencié de la glande thyroïde réfractaire | Carcinome de la glande thyroïde non résécable | Carcinome papillaire de la glande thyroïde réfractaire | Carcinome folliculaire de la glande thyroïde réfractaire | Carcinome réfractaire de la glande thyroïde Hurthle CellÉtats-Unis, Canada
Essais cliniques sur erlotinib [Tarceva]
-
University of UtahComplété
-
Hoffmann-La RocheComplétéCancer du poumon non à petites cellulesItalie, Espagne, Pays-Bas, France, Allemagne, Royaume-Uni
-
PfizerComplétéCarcinome pulmonaire non à petites cellulesÉtats-Unis
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Genentech, Inc.ComplétéCarcinome pulmonaire non à petites cellulesÉtats-Unis
-
Merck Sharp & Dohme LLCComplété
-
SCRI Development Innovations, LLCBayerComplétéCancer du poumon non à petites cellulesÉtats-Unis
-
Dartmouth-Hitchcock Medical CenterGenentech, Inc.; Ligand PharmaceuticalsComplétéCarcinome pulmonaire non à petites cellulesÉtats-Unis
-
SCRI Development Innovations, LLCNovartisComplétéCancer du poumon non à petites cellulesÉtats-Unis
-
Southern Illinois UniversityGenentech, Inc.; OSI PharmaceuticalsComplétéCancer de la tête et du couÉtats-Unis
-
New Mexico Cancer Care AllianceComplétéTumeurs malignes solides avancéesÉtats-Unis