A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer
Collecte de données
Maladies du système digestif+5
+ Néoplasmes du système digestif
+ Maladies du système endocrinien
Étude thérapeutique
Résumé
Phase I Primary Objective: * Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Phase II Primary Objective: * Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Phase II Secondary Objective: * Evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.111 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria * Pancreatic cancer (AJCC Stage II-IV); * Unresectable cancer; * Measurable disease (RECIST criteria); * No prior therapy; * ECOG Score 0-2 * Life expectancy greater then or equal to three months; * Adequate hematopoietic, liver and renal function; * Women of child-bearing potential must have negative urine/serum pregnancy test; * Signed written informed consent; * Subjects must be willing to be followed during the course of the treatment/observation and follow-up. Exclusion Criteria: * Prior therapy for pancreatic cancer; * Previously diagnosed brain metastases if symptomatic and requiring active therapy; * Other cancers within the last five years, with the exception of adequately treated cone-biopsied in-situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin; * Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study * Primary or secondary immunodeficiency, or use of corticosteroids immunosuppressive medication; * Women must not be pregnant or breast-feeding; * Participation in any clinical trial involving investigational drugs within one month from enrollment into the present study.