18
Participants
Start Date
October 22, 2019
Primary Completion Date
October 11, 2021
Study Completion Date
April 14, 2022
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.
Stony Brook University Cancer Center, Stony Brook
University of Kentucky, Lexington
Collaborators (1)
Ipsen
INDUSTRY
Barbara Ann Karmanos Cancer Institute
OTHER
University of Iowa
OTHER
Stony Brook University
OTHER