Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer
Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study
University Hospital, Ghent
45 participants
Nov 21, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria15
- 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)
Interventions
Nanoliposomal irinotecan (Nal-IRI, Onivyde) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 30 to 90 mg/m². PIPAC will be performed every 4 to 6 weeks for 3 cycles.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05277766