- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00813072
Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
A Randomized Phase II Study of PEP02, Irinotecan or Docetaxel as a Second Line Therapy in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Palliative chemotherapy has been shown to improve survival compared with best supportive care alone in patients with unresectable or recurrent gastric cancer. There is no standard second-line chemotherapy for advanced gastric cancer and no randomized-controlled trial data suggest a benefit of second-line chemotherapy compared with supportive care alone. Response rates of second-line therapy in phase II trials are similar to those seen for other cancers that are more commonly retreated. Combination therapy may achieve higher response rates than single agents, however, the survival outcome are the same. In addition, data suggest that patients may obtain symptomatic benefits from second-line therapy. In comparison to the toxicity profile of single agent with combination regimen, patients are more tolerable to single agent therapy than combination.
Based on the previous clinical experience in second line chemotherapy of advanced gastric cancer, the single agent of PEP02, irinotecan and docetaxel are selected as the regimens for this randomized phase II study. The efficacy and toxicity outcome of the three-arm design will be a valuable reference for future combination therapy or phase III study design.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Mostar, Bosnie Herzégovine, 36 000
- Clinical hospital Mostar
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Sarajevo, Bosnie Herzégovine, 71 000
- Clinical Centre University of Sarajevo
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Seoul, Corée, République de, 135-710
- Samsung Medical Center
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Seoul, Corée, République de, 138-736
- Asan Medical Center
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Seoul, Corée, République de, 410-769
- National Cancer Center
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Rijeka, Croatie, 51 000
- University Hospital Centre Rijeka
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Zagreb, Croatie, 10 000
- University Hospital Centre Zagreb
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Zagreb, Croatie, 10 000
- University Hospital Centre Dubrava
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Barcelona, Espagne, 08035
- Hospital Universitario Vall d'Hebron
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Elche, Espagne, 03203
- Hospital General Universitario de Elche
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Madrid, Espagne, 28040
- Hospital Clinico San Carlos
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Santander, Espagne, 39008
- Hospital Universitario Marques de Valdecilla
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Cambridge, Royaume-Uni, CB2 2QQ
- Addenbrookes Hospital Oncology Center
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London, Royaume-Uni, SE19RT
- Guy's & St Thomas' NHS Foundation Trust
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Maidstone, Royaume-Uni, ME16 9QQ
- Kent Oncology Centre, Maidstone Hospital
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Southampton, Royaume-Uni, SO16 6YD
- Southampton University Hospital
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Surrey, Royaume-Uni, SM2 5PT
- The Royal Marsden Hospital
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Chiayi, Taïwan
- Chang Gung Memorial Hospital - Chiayi
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LinKou, Taïwan
- Chang Gung Memorial Hospital - Linkou
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Tainan, Taïwan, 704
- National Cheng Kung University Hospital
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Taipei, Taïwan, 112
- Taipei Veterans General Hospital
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Taipei, Taïwan, 25115
- Mackay Memorial Hospital
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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:
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric or gastroesophageal junction
- Failed to only one systemic chemotherapy for locally advanced or metastatic disease, including patients whose diseases recur within 6 months after (neo)adjuvant chemotherapy. Chemotherapy administered with concurrent radiotherapy is NOT considered as systemic chemotherapy.
- Have at least one measurable lesion according to the RECIST criteria
- Aged above or equal to 18 years, at the time of acquisition of informed consent
- With ECOG performance status 0, 1, or 2
- Life expectancy equal to or more than 3 months
- With adequate organ and marrow function as defined below:
- With ability to understand and the willingness to sign a written Informed Consent Form
Exclusion Criteria:
- Had systemic chemotherapy within 3 weeks before the commencement of study treatment
- Had radiotherapy within 4 weeks before the commencement of study treatment
- With known brain metastasis
- With active multiple cancers or had treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- With prior irinotecan or taxane (paclitaxel, docetaxel) treatment
- Have received irradiation affecting > 30% of the active bone marrow
- Had major surgery within 4 weeks of the start of study treatment (laparotomy, line placement is not considered major surgery)
- Have not recovered from prior treatments
- With preexisting peripheral neuropathy > grade 2
- With history of allergic reaction to liposome product or other drugs formulated with polysorbate
- With uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, active gastrointestinal bleeding, watery stools, central nervous system disorders or psychiatric illness/social situation that would limit compliance with study requirements or judged to be ineligible for the study by the investigator
- Have received any investigational agents within 3 weeks preceding the start of study treatment
- Pregnant or breastfeeding females (a pregnancy test must be performed on all female patients who are of child-bearing potential before entering the study, and the result must be negative)
- With intestinal obstruction
- Have received St. John's Wort, CYP3A4 inducing anticonvulsants (phenytoin, phenobarbital, and carbamazepine), rifampin and rifabutin within two weeks, or ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem and verapamil within one week before the administration of study medications
Plan d'étude
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 |
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Expérimental: 1. PEP02
liposome irinotecan
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120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Autres noms:
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Comparateur actif: 2. irinotecan
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300 mg/m2, IV infusion on day 1 of each 21 day as a treatment cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
Autres noms:
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Comparateur actif: 3. docetaxel
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75 mg/m2, IV infusion for 60 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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réponse tumorale objective
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Mesures de résultats secondaires
Mesure des résultats |
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progression-free survival, duration of tumor response, time to progression, time to treatment failure, disease control rate, 1-year survival rate,and overall survival; pharmacokinetics and pharmacogenetics of PEP02 and irinotecan
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: David Cunningham, The Royal Marsden Hospital, London & Surrey, UK
Publications et liens utiles
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
- Tumeurs par type histologique
- Tumeurs par site
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Tumeurs de la tête et du cou
- Maladies de l'oesophage
- Tumeurs
- Tumeurs de l'estomac
- Adénocarcinome
- Tumeurs de l'oesophage
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Inhibiteurs de la topoisomérase
- Inhibiteurs de la topoisomérase I
- Docétaxel
- Irinotécan
Autres numéros d'identification d'étude
- PEP0206
- EudraCT number: 2006-006452-35
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 PEP02
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PharmaEngineComplétéCancer colorectal métastatiqueTaïwan
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PharmaEngineComplété
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Merrimack PharmaceuticalsComplétéCancer du pancréas métastatiqueÉtats-Unis, France, Royaume-Uni, Allemagne, Taïwan, Espagne, Argentine, Afrique du Sud, Corée, République de, Canada, Brésil, République tchèque, Hongrie, Italie, Australie
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Emory UniversityIpsen; Taiho Oncology, Inc.RecrutementAdénocarcinome gastrique | Carcinome pancréatique non résécable | Adénocarcinome pancréatique métastatique | Cancer du pancréas de stade III | Cancer du pancréas de stade IV | Adénocarcinome colorectal | Cancer gastrique de stade IV | Cancer colorectal de stade IV | Cancer colorectal de stade IVA | Cancer... et d'autres conditionsÉtats-Unis
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University of Southern CaliforniaNational Cancer Institute (NCI); IpsenRetiréAdénocarcinome gastrique | Adénocarcinome métastatique de la jonction gastro-oesophagienne | Adénocarcinome de la jonction gastro-oesophagienne non résécable | Adénocarcinome de la jonction gastro-oesophagienne | Adénocarcinome gastrique non résécable localement avancé | Adénocarcinome gastrique...États-Unis
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Institut de Recherches Internationales ServierPas encore de recrutement
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GERCOR - Multidisciplinary Oncology Cooperative...Résilié
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Roswell Park Cancer InstituteIpsenActif, ne recrute pasCarcinome neuroendocrinien pancréatique non résécable | Carcinome neuroendocrinien du système digestif localement avancé | Carcinome neuroendocrine pancréatique localement avancé | Carcinome neuroendocrinien métastatique du système digestif | Carcinome neuroendocrine pancréatique métastatique et d'autres conditionsÉtats-Unis
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National Cancer Institute (NCI)Actif, ne recrute pasTumeur solide maligneÉtats-Unis
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Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsComplétéCarcinome récurrent des trompes de Fallope | Carcinome ovarien récurrent | Carcinome péritonéal primitif récurrent | Carcinome des trompes de Fallope résistant au platine | Carcinome péritonéal primaire résistant au platine | Carcinome de l'ovaire résistant au platine | Carcinome ovarien réfractaire et d'autres conditionsÉtats-Unis