Phase I Trial HIPEC With Nal-irinotecan

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

October 22, 2019

Primary Completion Date

October 11, 2021

Study Completion Date

April 14, 2022

Conditions
Peritoneal CancerPseudomyxoma PeritoneiMucinous AdenocarcinomaMucinous TumorColorectal CancerGastric CancerPrimary Peritoneal CarcinomaMesothelioma
Interventions
DRUG

nanoliposomal irinotecan

The starting dose of nal-IRI will be 70 mg/m2 (cohort level 1) applied for 30 min using a closed HIPEC technique following completion of cytoreductive surgery. If there is dose limiting toxicity (DLT) in cohort level 1, then the dose will be reduced the dosage of the next cohort to 50 mg/m2 (cohort level 0). If there is no DLT, the dose of nal-IRI will be increased to 140 mg/m2, 210 mg/m2 and 280 mg/m2 . If one of the patients experiences DLT, then the cohort will expand to 6 patients and accrual to the current dose level and dose escalation will stop if 2 or more patients experience a DLT at a given dose level.

Trial Locations (2)

11794

Stony Brook University Cancer Center, Stony Brook

40536

University of Kentucky, Lexington

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ipsen

INDUSTRY

collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

collaborator

University of Iowa

OTHER

lead

Stony Brook University

OTHER