Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer

Korábbi kezelés

• Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)
• Patients known to use:
  • CYP3A4 inducers (rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St John's wort)
  • inhibitors of CYP3A4 (clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (atazanavir, gemfibrozil, indinavir, regorafenib)

Más betegség

• Known allergy or intolerance to irinotecan
• Extensive hepatic and/or extra-abdominal metastatic disease

Laborértékek

• Impaired renal function (serum creatinine > 1.5 mg/dl or calculated GFR (CKD-EPI) < 60 mL/min/1.73 m²
• Impaired liver function (serum total bilirubin > 1.5 mg/dl, except for known Gilbert's disease)
• Platelet count < 100.000/µl
• Hemoglobin < 9g/dl
• Neutrophil granulocytes < 1.500/ml

Életkor

• Patients of childbearing age unable or unwilling to provide effective contraception during the study and until the end of relevant exposure (extended by 30 days (female participants) or 120 days (male participants) since the IMP is genotoxic).

Egyéb

• Pregnancy or breastfeeding during the clinical study
• Significant amount of ascites detectable (exceeding 3l in volume)
• Intestinal or urinary tract obstruction

• Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis
• Estimated life expectancy > 6 months; > 3 months if primary cancer is pancreatic
• Age ≥ 18 years
• Adequate performance status (Karnofsky index > 60% and WHO performance status < 2)
• Written informed consent obtained prior any act of the research