A Phase I/II Study of Aroplatin and Capecitabine in Subjects With Unresectable Local Recurrence or Distant Metastases of Colorectal Cancer Refractory to 5-FU/Leucovorin and Irinotecan
Collecte de données
Maladies du côlon+8
+ Maladies du système digestif
+ Néoplasmes du système digestif
Étude thérapeutique
Résumé
Phase I Primary Objective: * Determine the MTD of Aroplatin/capecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FU/LV and irinotecan. Phase II Primary Objective: * Evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Phase II Secondary Objective: * Evaluate the frequency of adverse events.
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.105 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: * Histologically confirmed colorectal cancer: unresectable local recurrence or distant metastases; * Measurable disease (RECIST criteria); * Refractory to 5-FU / leucovorin and irinotecan as described below; * No prior therapy with oxaliplatin, any other platinum or capecitabine; * ECOG score 0-2 (Karnofsky 100-70%); * Life expectancy of greater then or equal to 5 months; * Adequate hematopoietic, liver and renal function; * Women of child-bearing potential have to practice adequate contraception; * Signed written informed consent; * Subjects must be willing to be followed during the course of treatment/observation and follow-up. Refractory metastatic colorectal cancer The following subjects are regarded refractory to treatment: * Those with progression while receiving 5-FU/LV/irinotecan; * Those with progression on irinotecan after prior 5-FU/LV treatment; * Progression within six months of adjuvant 5-FU/LV/irinotecan; * Progression within six months of adjuvant 5-FU/LV followed by progression on irinotecan Subjects must have received at least one or more commonly used 5-FU/leucovorin and irinotecan regimens. Prior adjuvant therapy is allowed including 5-FU/leucovorin or other fluoropyrimidines except capecitabine and irinotecan. Exclusion criteria: * 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; * Concurrent chemotherapy or immunotherapy; * Prior therapy for colorectal cancer within one month of admission to the present study; * Primary or secondary immunodeficiency or use of corticosteroids or other immunosuppressive medication; * Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study; * Women must not be pregnant or breast-feeding; * No participation in any clinical trial involving investigational drugs within 1 month from enrollment into the present study.