Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study

Trial ID: NCT05277766

Interventional - Phase 1 - Active, not recruiting

The PIPAC NAL-IRI study is designed to examine the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a monocentric, phase I trial.

Conditions

• Peritoneal Carcinomatosis
• Peritoneal Metastases
• Colorectal Cancer
• Small Bowel Cancer
• Appendix Cancer
• Gastric Cancer
• Pancreatic Cancer
• Bile Duct Cancer

Interventions

• PIPAC with Nal-IRI

Eligibility

Inclusion criteria

• 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

Exclusion criteria

• Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)
• Pregnancy or breastfeeding during the clinical study
• 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).
• Known allergy or intolerance to irinotecan
• Significant amount of ascites detectable (exceeding 3l in volume)
• Intestinal or urinary tract obstruction
• Extensive hepatic and/or extra-abdominal metastatic disease
• 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
• 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)

Sponsor

University Hospital, Ghent, Kom Op Tegen Kanker, University Ghent

Source: ClinicalTrials.gov

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