Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study
Who is this study for? Patients with peritoneal carcinomatosis from gastrointestinal cancer
What treatments are being studied? PIPAC with Nal-IRI
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
UZ Ghent
RECRUITING
Ghent
Contact Information
Primary
Wim P Ceelen, MD, PhD, Prof
wim.ceelen@ugent.be
+3293326251
Time Frame
Start Date: 2022-11-21
Estimated Completion Date: 2027-04
Participants
Target number of participants: 45
Treatments
Experimental: Nal-IRI (Onivyde) - 30mg/m²
PIPAC with Onivyde (30 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.
Experimental: Nal-IRI (Onivyde) - 45mg/m²
PIPAC with Onivyde (45 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.
Experimental: Nal-IRI (Onivyde) - 60mg/m²
PIPAC with Onivyde (60 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.
Experimental: Nal-IRI (Onivyde) - 75mg/m²
PIPAC with Onivyde (75 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.
Experimental: Nal-IRI (Onivyde) - 90mg/m²
PIPAC with Onivyde (90 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.
Related Therapeutic Areas
Sponsors
Collaborators: University Ghent, Kom Op Tegen Kanker
Leads: University Hospital, Ghent