Aerosolized Nanoliposomal Irinotecan for Peritoneal Carcinomatosis from Gastrointestinal Cancer
Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study
This study is testing a new way to deliver a cancer drug directly to the abdomen to see if it helps people with advanced gastrointestinal cancer that has spread to the lining of the abdomen feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ghent, East-Flanders) |
| Trial ID | NCT05277766 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of aerosolized nanoliposomal irinotecan (Nal-IRI) delivered via pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with peritoneal carcinomatosis stemming from gastrointestinal cancers. It is a phase I dose-finding study aimed at determining the maximum tolerated dose of Nal-IRI while assessing its pharmacokinetics and potential clinical benefits. The trial focuses on patients with extensive or irresectable peritoneal metastases, who often experience severe symptoms and poor prognosis. By utilizing a novel delivery method, the study seeks to improve drug efficacy and patient outcomes compared to traditional systemic chemotherapy.
Who should consider this trial
Good fit: Ideal candidates include adults with biopsy-proven gastrointestinal cancers and extensive peritoneal carcinomatosis who have a life expectancy of more than six months.
Not a fit: Patients currently receiving systemic treatment with irinotecan or those with significant ascites may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance treatment options and quality of life for patients suffering from peritoneal carcinomatosis.
How similar studies have performed: While this approach is innovative, similar studies using PIPAC have shown promise in treating peritoneal metastases, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Ghent, East-Flanders
- UZ Ghent — Ghent, East-Flanders, Belgium (Recruiting)
Study contacts
- Principal investigator: Wim P Ceelen, MD, PhD, Prof — University Hospital, Ghent
- Study coordinator: Wim P Ceelen, MD, PhD, Prof
- Email: wim.ceelen@ugent.be
- Phone: +3293326251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.