- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00123851
Tarceva, Capecitabine and Oxaliplatin for Metastatic Colorectal Cancer
A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, États-Unis, 02115
- Beth Israel Deaconess Medical 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:
- Ability to understand and the willingness to sign a written informed consent document.
- Patients with histologic proof of adenocarcinoma of the colon or rectum (colorectal carcinoma) with evidence of metastatic disease.
- Patients must have received one (and only 1) prior chemotherapy regimen for metastatic disease. Patients who received adjuvant therapy and then 1 regimen for metastatic disease are eligible. Patients who received adjuvant therapy and recur within 12 months of completion of adjuvant therapy are also eligible.
- Patients who have received prior radiation therapy, either in the adjuvant or metastatic setting, for colorectal carcinoma.
All of the following must apply:
- Greater than 4 weeks must have elapsed from the time of major surgery and patients must have recovered from the effects (e.g., laparotomy); *Greater than 2 weeks must have elapsed from the time of minor surgery and patients must have recovered from the operation. (Insertion of a vascular access device is not considered major or minor surgery.);
- Greater than 4 weeks must have elapsed from the time of major radiotherapy [RT] (e.g., chest or bone palliative RT);
- Greater than 4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities;
- Greater than 4 weeks must have elapsed from the participation in any investigational drug study.
- ECOG performance status < 2 ; life expectancy > 12 weeks
- Patients must have normal organ and marrow function as defined below:
ANC > 1500/mm3; hemoglobin > 9.0 gm/dl; platelets > 100,000/mm3; SGOT < 2.5x upper limits of normal if no evidence of liver metastases or < 5x upper limits of normal if evidence of liver metastases; total bilirubin < 1.5x upper limits of normal; Alk Phos < 2.5x upper limits of normal (or < 5x upper limits of normal if evidence of liver metastases or < 10x upper limits of normal if evidence of bone disease).
Exclusion Criteria:
- Patients with peripheral neuropathy of grade 2 or greater severity.
- Uncontrolled high blood pressure.
- Unstable angina.
- Symptomatic congestive heart failure.
- Myocardial infarction < 12 months prior to registration.
- Serious uncontrolled cardiac arrhythmia.
- New York Heart Association classification III or IV.
- Active or uncontrolled infection.
- Medical or psychiatric conditions which, in the opinion of the investigator, make participation in an investigational trial of this nature a poor risk.
- Patients with known brain metastases or carcinomatous meningitis should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- No concurrent malignancy of any site, except for limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration and agree to use an effective method of contraception.
- Patients who are pregnant or lactating.
- Patients with prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
- Patients previously treated with oxaliplatin, OSI-774 or another epidermal growth factor inhibitor (EGFR).
- Patients lacking physical integrity of the upper gastrointestinal tract.
- Patients with other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
Plan d'étude
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)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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To determine the response rate of OSI-774 when given in combination with oxaliplatin and capecitabine in patients with previously-treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma
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Mesures de résultats secondaires
Mesure des résultats |
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To assess overall survival, progression-free survival, time to progression and duration of response
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To evaluate the toxicities of the combination of OSI-774, oxaliplatin and capecitabine in this population of patients with colorectal cancer
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
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
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Processus pathologiques
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies du côlon
- Maladies intestinales
- Tumeurs intestinales
- Maladies rectales
- Processus néoplasiques
- Tumeurs colorectales
- Métastase néoplasmique
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Inhibiteurs de protéine kinase
- Chlorhydrate d'erlotinib
- Capécitabine
- Oxaliplatine
Autres numéros d'identification d'étude
- 02-269
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 Oxaliplatine
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SanofiComplété
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SanofiComplétéCancer de l'estomacCorée, République de
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SanofiComplétéTumeurs pancréatiquesCanada