Phase I Trial HIPEC With Nal-irinotecan

Phase 1 Completed 18 enrolled Stony Brook University Barbara Ann Karmanos Cancer Institute · collab Ipsen · collab University of Iowa · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.

Timeline

Start: 2019-10-22
Primary completion: 2021-10-11
Completion: 2022-04-14

Publications

McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	50 mg/m2	Other
Subject	Irinotecan	Small molecule	70 mg/m2	Other
Subject	Irinotecan	Small molecule	140 mg/m2	Other
Subject	Irinotecan	Small molecule	210 mg/m2	Other
Subject	Irinotecan	Small molecule	280 mg/m2	Other

Phase I Trial HIPEC With Nal-irinotecan

Summary

Timeline

Publications

Drugs

Indications