- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00215982
Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer
21 novembre 2013 mis à jour par: H. Lee Moffitt Cancer Center and Research Institute
A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin (Eloxatin) in Adult Patients With Advanced Colorectal Cancer
The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer.
All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer.
This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The primary objective of the study is to determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan.
Secondary objectives are to determine the time to tumor progression and the toxicity and tolerability of Oxaliplatin, Capecitabine and Irinotecan when administered in combination.
Study schema is as follows.
Cycles are 42 days long.
Patients will receive Oxaliplatin and Capecitabine on day 1.
Capecitabine is an oral pill that will be taken for 14 days.
Patients return again on day 21 when they receive Irinotecan and Capecitabine.
Capecitabine again is taken for 14 days.
CT scans are performed at the end of the 6 week cycle to determine response.
Type d'étude
Interventionnel
Inscription (Réel)
24
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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Rio Piedras, Porto Rico, 00927-4840
- San Juan Veterans Hospital
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Florida
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Tampa, Florida, États-Unis, 33612
- H. Lee Moffitt Cancer Center & Research Institute
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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:
- Patients must have histological or cytological confirmed metastatic colorectal cancer.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- No prior chemotherapy in the metastatic setting (prior fluorouracil chemotherapy, if administered in the adjuvant setting, and if more than 6 months has passed since the completion of therapy, is allowable). Prior adjuvant radiation therapy allowable provided no greater than 30% total bone marrow included in the field (must be more than 6 weeks since completion of radiation therapy.
- Subject must be 18 years or older
- Life expectancy greater than 12 weeks.
- ECOG performance status <2 (Karnofsky >60%).
- Patients must have normal organ and marrow function as defined as: leukocytes >3,000/mcL; absolute neutrophil count >1,500/mcL; Platelets >100,000/mcL; total bilirubin within normal institutional limits; AST(SGOT)/ALT (SGPT) <2.5 X institutional upper limit of normal; Creatinine within normal institutional limits and Creatinine clearance (estimated by Cockcroft-Gault equation)>50-mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential).
- Woman of childbearing potential with either a positive or no pregnancy test at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior therapy for MCRC in the metastatic setting.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases will 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.
- Grade 2 or greater peripheral neuropathy.
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Pregnant and nursing women are excluded from this study. Women / men of childbearing potential not using a reliable and appropriate contraceptive method.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Oxaliplatin and Irinotecan or other agents administered during the study.
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
- History of persistent neurosensory disorder including but not limited to peripheral neuropathy
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Any prior platinum based therapy
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: Combination Therapy
Capecitabine in Combination with Irinotecan and Oxaliplatin
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Capecitabine will be administered at a dose of 825 mg/m2 PO BID, for a total daily dose of 1650 mg/m2.
Capecitabine will be administered on days 1-14 followed by 7 day treatment free rest period and days 21-35 followed by a 7 day treatment-free rest period, every six weeks (42 days) of treatment is considered one cycle.
Autres noms:
Oxaliplatin will be administered at a dose of 130 mg/m2 IV over 120 minutes in 250-500 ML D5W on day 1, every 42 days.
Autres noms:
Irinotecan will be administered at a dose of 180mg/m2 IV over 90 minutes on day 21 every 42 days.
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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response rate
Délai: average of 12 months
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To determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan
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average of 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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time to tumor progression
Délai: average of 12 months
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To determine the time to tumor progression in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan
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average of 12 months
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toxicity and tolerability
Délai: average of 12 months
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To determine the toxicity and tolerability of Oxaliplatin, Capecitabine and Irinotecan when administered in combination
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average of 12 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Christopher Garrett, MD, H. Lee Moffitt Cancer Center & Research Institute (now at M.D. Anderson)
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
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 décembre 2004
Achèvement primaire (Réel)
1 juillet 2007
Achèvement de l'étude (Réel)
1 juillet 2007
Dates d'inscription aux études
Première soumission
19 septembre 2005
Première soumission répondant aux critères de contrôle qualité
19 septembre 2005
Première publication (Estimation)
22 septembre 2005
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
25 novembre 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 novembre 2013
Dernière vérification
1 septembre 2010
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies du côlon
- Maladies intestinales
- Tumeurs intestinales
- Maladies rectales
- Tumeurs colorectales
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Inhibiteurs de la topoisomérase
- Inhibiteurs de la topoisomérase I
- Capécitabine
- Oxaliplatine
- Irinotécan
Autres numéros d'identification d'étude
- MCC-13424
- XEL351 (Autre identifiant: Roche)
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 .
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