Safety and Effectiveness of Treating Cancers With the Litx™ System and Chemotherapy. Section A: Phase II Safety and Effectiveness Study in Patients With Liver Metastases From Colorectal Cancer
Collecte de données
Maladies du côlon+14
+ Maladies du système digestif
+ Néoplasmes du système digestif
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 2004
Date à laquelle le premier participant a commencé l'étude.Patients that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Sources may be used in a single lesion or in multiple lesions. Following radiographic confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 40 mg/m². Fifteen minutes to 1 hour following completion of LS11 administration, delivery of 200 J/cm at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for acute complication of Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and be maintained as defined throughout the study period. On day 3 following Litx™ treatment the patient will receive a standard chemotherapy with Irinotecan or Oxaliplatin with or without 5FU and /or leucovorin for metastatic colorectal cancer. On day 30+5 and day 60+5 the patient will undergo clinical assessment and the tumor mass will be imaged using contrast enhanced spiral CT for determination of volume and radius of PDT necrosis.
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.25 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: * Patients with metastatic liver lesions from colorectal disease * Biopsy proven evidence of colorectal cancer * Patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter * Age greater than or equal to 18 years * Patients must be able to sign informed consent * Life expectancy greater than or equal to 3 months * ECOG performance status 0-2 * Patients with extrahepatic disease in addition to their hepatic metastases may be eligible * Must have recovered from the toxicity from any prior antineoplastic therapy Exclusion Criteria: * Patients who are candidates for complete surgical resection * Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment * Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study * PT or PTT greater than 1.5X control * Platelet count less than 100,000 * WBC less than 2500/mm * Neutrophils less than 2000/mm * Hemoglobin less than 9 g/dL * Liver enzymes (AST, ALT, GGT, alkaline phosphatase) greater than 3 X ULN * Total bilirubin greater than 1.5 X ULN * Serum creatinine greater than 2.5 X ULN * Patients who have been treated with either AVASTIN™ (Bevacizumab) or ERBITUX™ (Cetuximab) within the previous 4 weeks (28 days)
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site