- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00523419
Chemotherapy for Patients With Osteosarcoma
24 juin 2011 mis à jour par: Eli Lilly and Company
Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas
The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition.
- To assess how well treatment with pemetrexed works for patients with your type of cancer
- To assess for any side effects that might be associated with pemetrexed.
- To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Réel)
32
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
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Heidelberg, Allemagne, 69120
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Munich, Allemagne, 81377
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Espagne, 08025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Espagne, 28050
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pamplona, Espagne, 31008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bordeaux, France, 33076
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lyon, France, 69437
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Marseille, France, 13385
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Villejuif, France, 94805
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bologna, Italie, 40136
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Milano, Italie, 20133
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Torino, Italie, 1053
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tyneside
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Newcastle-Upon-Tyne, Tyneside, Royaume-Uni, NE4 6BE
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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:
- Histological diagnosis of high grade locally advanced or metastatic osteosarcoma
- Must have one prior chemotherapy regimen for advanced disease
- At least 1 unidimensional measurable lesion by computed tomography (CT) scan
- Have a good performance status
- Adequate organ function
Exclusion Criteria:
- Have a serious concomitant systemic disorder (for example active Human Immunodeficiency Virus infection)
- Have brain metastases not adequately treated
- Significant weight loss (that is more than 20%) over the previous 6 weeks before study entry
- Inability or unwillingness to take folic acid or vitamin B12 supplementation and corticosteroids
- Pregnant or breast-feeding
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: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Pemetrexed
Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle.
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500 mg/m^2, IV every 21 days until disease progression, unacceptable toxicity, participant or physician's decision.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants With Tumor Response
Délai: Baseline to 21 months
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Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) = at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria.
Tumor Response Rate(%) = sum of number of PR + CR observed/number of participants qualified for tumor response analysis * 100.
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Baseline to 21 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Time to Treatment Failure
Délai: Baseline to 21 months
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When the protocol was written, time to treatment failure (TTTF) was included as a secondary endpoint.
However, it was subsequently realized that due to the design of the study, participants are treated until disease progression or discontinuation from study treatment, not for a fixed number of cycles.
Therefore, it was concluded that analysis of TTTF was inappropriate with the current study design and the analysis was not conducted, since it would be essentially the same as Progression-Free Survival.
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Baseline to 21 months
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Correlation of Disease Outcome With Pharmacogenomic Analysis
Délai: Baseline to 21 months
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It was planned to examine methylthioadenosine phosphorylase (MTAP) gene deletion, folate receptor alpha (FRα) and folylpoly-gamma-glutamate synthetase (FPGS) expression, and to correlate the results with the clinical data to determine the association between these factors and clinical outcome to treatment.
However, due to the small number of participants with partial response (n=1), the planned statistical analyses that would correlate responders/non responders with pharmacogenomics data are no longer valid and the analyses were not conducted.
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Baseline to 21 months
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Number of Participants With Adverse Events (Pharmacology Toxicity)
Délai: Baseline to 21 months
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Pharmacology toxicity was defined as serious and non-serious adverse events.
Summaries of these adverse events are located in the Reported Adverse Event Section.
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Baseline to 21 months
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Duration of Response
Délai: Baseline to 31 months
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The duration of a complete response (CR) or partial response (PR) was defined as the time from the first objective status assessment of CR or PR to the first date of progression or death as a result of any cause: CR was achieved if all tumor lesions disappeared; PR was achieved if there was >=30% decrease in sum of the longest diameter (LD) of target lesions (reference: baseline sum LDs) or complete disappearance of target lesions with persistence (but not worsening) of >=1 nontarget lesions and no appearance of new lesions.
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Baseline to 31 months
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Progression-Free Survival (PFS)
Délai: Baseline to 10.4 months
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PFS was from date of study enrollment to first date of objectively determined progressive disease (PD) or death from any cause.
For participants who did not die as of data cut-off date and who did not have objective PD, PFS was censored at date of last objective progression-free disease assessment.
For participants who received subsequent systemic anticancer therapy (after discontinuation from study drug) before objectively determined disease progression or death, PFS was censored at date of last objective progression-free disease assessment, before post-discontinuation chemotherapy.
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Baseline to 10.4 months
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Overall Survival (OS) Time
Délai: Baseline to 27.6 months
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OS was the duration from enrollment to death.
For participants who lived, OS was censored at the last contact.
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Baseline to 27.6 months
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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 septembre 2007
Achèvement primaire (Réel)
1 juin 2009
Achèvement de l'étude (Réel)
1 juin 2010
Dates d'inscription aux études
Première soumission
29 août 2007
Première soumission répondant aux critères de contrôle qualité
29 août 2007
Première publication (Estimation)
31 août 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
28 juin 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juin 2011
Dernière vérification
1 juin 2011
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs, tissus conjonctifs et mous
- Tumeurs par type histologique
- Tumeurs
- Tumeurs, tissu osseux
- Tumeurs, tissu conjonctif
- Sarcome
- Ostéosarcome
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs de la synthèse des acides nucléiques
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Antagonistes de l'acide folique
- Pémétrexed
Autres numéros d'identification d'étude
- 11814
- H3E-EW-S115 (Autre identifiant: Eli Lilly and Company)
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 Pemetrexed
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Rongjie TaoNational Natural Science Foundation of ChinaInconnueMétastases cérébralesChine
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CanBas Co. Ltd.ComplétéTumeurs solides | Mésothéliome pleural malinÉtats-Unis
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Northwestern UniversityNational Cancer Institute (NCI)InconnueLymphome | Tumeurs du cerveau et du système nerveux central | Cancer métastatiqueÉtats-Unis
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PfizerRésiliéCarcinome, poumon non à petites cellulesÉtats-Unis, Allemagne, Italie
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Ain Shams UniversityInconnue
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Threshold PharmaceuticalsEMD SeronoRésiliéCancer du poumon non à petites cellulesÉtats-Unis, Allemagne, Espagne, Pologne, Grèce, Tchéquie, Hongrie, Italie, Roumanie, Fédération Russe
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The First Affiliated Hospital with Nanjing Medical...InconnueCancer du poumon non à petites cellules non épidermoïde
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Incyte CorporationMirati Therapeutics Inc.RecrutementTumeurs solides avancéesÉtats-Unis, Canada, Espagne, Royaume-Uni, Italie
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Spanish Lung Cancer GroupRésiliéCarcinome pulmonaire non à petites cellulesEspagne
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PfizerComplétéNSCLC (cancer du poumon non à petites cellules)Hong Kong, Chine, Taïwan, Malaisie, Thaïlande