Phase I Trial HIPEC With Nal-irinotecan

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Minsig Choi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Stony Brook University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Patients with pseudomyxoma peritonei or peritoneal carcinomatosis of digestive origin or primary peritoneum: appendiceal mucinous tumor or adenocarcinoma (including goblet cell cancer and signet ring cell cancer), colorectal cancer, gastric cancer, primary peritoneal adenocarcinoma, and mesothelioma; regardless of the number of prior treatment lines. Diagnosis of peritoneal metastasis to be confirmed via either clinical or histopathology assessment.

Age ≥18 years

Eastern Cooperative Oncology Group performance status of 0 or 1

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

Cytoreductive surgery (CRS) followed by study treatment with nanoliposomal irinotecan administered intraperitoneally.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Kentucky Lexington, KY

Stony Brook University Cancer Center Stony Brook, NY

Who Is Running the Clinical Trial?

Stony Brook University Lead Sponsor

University of Iowa Collaborator

Ipsen Industry Sponsor

Barbara Ann Karmanos Cancer Institute Collaborator

References