- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02004769
Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer
Phase II Study of Trastuzumab in Combination With Chemotherapy (Docetaxel Plus Capecitabine) For First Line Treatment of Her2-Positive Advanced Gastric or Gastro-Esophageal Junction Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Guangdong
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Guangzhou, Guangdong, Chine, 510060
- Medical Oncology,Sun Yat-sen University Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Male or female. Age: 18-75 years.
- Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, assessed using imaging techniques (CT or MRI).
- HER2 positive tumor (primary tumor or metastasis, HER2 positive as defined by IHC2+ and a confirmatory FISH+ result (HER2:CEP17 ratio ≥2), or by an IHC 3+ result) as assessed by the central laboratory. Accurate and validated assay methods will be used.
- ECOG Performance status 0-1.
- Life expectancy of at least 3 months.
- Signed informed consent.
- Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrollment into the study; adjuvant/neoadjuvant therapy with docetaxel is not allowed).
9 .Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe).
10. Patients with active (significant or uncontrolled) gastrointestinal bleeding.
11. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurologic toxicity ≥ grade 2 NCI-CTCAE version 4.0.
12. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
13. Hematologic, Biochemical and Organ Function 14. Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L. 15. Serum bilirubin > 1.5 × upper limit of normal (ULN); or, AST or ALT > 2.5 × ULN (or > 5 × ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 × ULN (or > 5 × ULN in patients with liver metastases, or > 10 × ULN in patients with bone but no liver metastases); or albumin < 25 g/L.
16. Creatinine clearance < 60 mL/min.
Exclusion Criteria:
- History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
- Baseline LVEF < 50% (measured by echocardiography or MUGA).
- Patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
- Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- History or clinical evidence of brain metastases.
- Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- Positive serum pregnancy test in women of childbearing potential.
- Subjects with reproductive potential not willing to use an effective method of contraception.
- Received any investigational drug treatment within 4 weeks of start of study treatment.
- Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recovered from any acute toxicity).
- Major surgery within 4 weeks of start of study treatment, without complete recovery.
- Patients with known active infection with HIV, HBV, or HCV.
- Known hypersensitivity to any of the study drugs.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- 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: Trastuzumab, Capecitabine, Docetaxel
Trastuzumab(8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) Capecitabine(2000mg/m2d, d1-14,every 3 weeks) Docetaxel (60mg/m2 every 3 weeks for 6 cycles).All patients will continue to receive trastuzumab and Capecitabine until either disease progression, occurrence of unacceptable toxicity or withdrawal from the study for another reason.
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Trastuzumab (Herceptin) will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v.
infusion every 3 weeks (q3w), until disease progress or intolerable toxicity.
Autres noms:
Docetaxel 60mg/m2 (on day 1) every 3 weeks for 6 cycles.
Autres noms:
Capecitabine (Xeloda) 2000mg/m2d, d1-14, every 3 weeks until disease progress or intolerable toxicity.
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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PFS(Progression-free survival )
Délai: up to 4 years
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The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death,
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up to 4 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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ORR (Overall tumor response)
Délai: up to 4 years
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Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.
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up to 4 years
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OS (Overall survival )
Délai: up to 4 years
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Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
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up to 4 years
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Safety
Délai: up to 4 years
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Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.
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up to 4 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ruihua Xu, M.D,Ph.D, Sun Yat-Sen University
Publications et liens utiles
Publications générales
- Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.
- Sawada N, Ishikawa T, Fukase Y, Nishida M, Yoshikubo T, Ishitsuka H. Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by taxol/taxotere in human cancer xenografts. Clin Cancer Res. 1998 Apr;4(4):1013-9.
- Roth AD, Fazio N, Stupp R, Falk S, Bernhard J, Saletti P, Koberle D, Borner MM, Rufibach K, Maibach R, Wernli M, Leslie M, Glynne-Jones R, Widmer L, Seymour M, de Braud F; Swiss Group for Clinical Cancer Research. Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: a randomized phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol. 2007 Aug 1;25(22):3217-23. doi: 10.1200/JCO.2006.08.0135.
- Thuss-Patience PC, Kretzschmar A, Repp M, Kingreen D, Hennesser D, Micheel S, Pink D, Scholz C, Dorken B, Reichardt P. Docetaxel and continuous-infusion fluorouracil versus epirubicin, cisplatin, and fluorouracil for advanced gastric adenocarcinoma: a randomized phase II study. J Clin Oncol. 2005 Jan 20;23(3):494-501. doi: 10.1200/JCO.2005.02.163.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Processus pathologiques
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Processus néoplasiques
- Tumeurs
- Tumeurs de l'estomac
- Métastase néoplasmique
- Mécanismes moléculaires de l'action pharmacologique
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques immunologiques
- Docétaxel
- Trastuzumab
- Capécitabine
Autres numéros d'identification d'étude
- ML28670
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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 Trastuzumab
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National Cancer Institute (NCI)NRG OncologyActif, ne recrute pasCarcinome canalaire du sein in situÉtats-Unis, Canada, Porto Rico, Corée, République de
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Tanvex BioPharma USA, Inc.ComplétéCancer du sein | Tumeurs mammaires | Cancer du sein HER2 positif | Cancer du sein de stade II | Cancer du sein de stade IIIA | Cancer du sein à un stade précoceBiélorussie, Chili, Géorgie, Hongrie, Inde, Mexique, Pérou, Philippines, Fédération Russe, Ukraine
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecrutementCancer du sein HER2 positif | Cancer du sein à un stade précoce | Traitement Adjuvant Après Trastuzumab | Classement RCB 1-2 | NeratiniChine
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NRG OncologyNational Cancer Institute (NCI)RecrutementCarcinome récurrent des glandes salivaires | Cancer majeur des glandes salivaires de stade III AJCC v8 | Cancer majeur des glandes salivaires de stade IV AJCC v8 | Carcinome métastatique des glandes salivaires | Carcinome des glandes salivaires non résécableÉtats-Unis
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Fudan UniversityHoffmann-La RocheInconnue
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Spanish Breast Cancer Research GroupComplété
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Fudan UniversityComplété
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National Cancer Institute (NCI)Actif, ne recrute pasCarcinome du sein masculin | Cancer du sein de stade IIA AJCC v6 et v7 | Cancer du sein de stade IIB AJCC v6 et v7 | Cancer du sein de stade IIIA AJCC v7 | Cancer du sein de stade IIIB AJCC v7 | Cancer du sein de stade IIIC AJCC v7États-Unis, Porto Rico
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AstraZenecaDaiichi SankyoComplétéCancer du seinDanemark, Finlande, Italie, Norvège, Espagne, Suède, Pologne, États-Unis, Canada, Allemagne, Japon, Pays-Bas, Le Portugal, Suisse, Australie, Royaume-Uni, Belgique, Irlande
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Orano Med LLCComplétéTumeurs de l'estomac | Tumeurs mammaires | Tumeurs pancréatiques | Tumeurs ovariennes | Tumeurs péritonéalesÉtats-Unis