Intraperitoneal Paclitaxel-loaded TPM for Treatment of Peritoneal Carcinomatosis

Peritoneal Carcinomatosis Clinical Trial

Official title: Phase I Trial of Intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) for Treatment of Peritoneal Carcinomatosis

Status Recruiting

Clinical Trial Summary

A first-in-human, unblinded, phase I trial of Paclitaxel-loaded tumor penetrating microparticles (TPM) in peritoneal carcinomatosis patients who are not eligible for standard-of-care therapeutic interventions.

Clinical Trial Description

This is a first in human study of Paclitaxel-loaded TPM, suspended in 0.5 L of 0.1% polysorbate 80 in normal saline instilled into the peritoneal cavity.

An enrolled patient will (a) undergo laparoscopy during which time the hydrostatic pressures at different locations within the peritoneal cavity are measured, pretreatment tumors are biopsied and peritoneal catheter is placed, (b) receive intraperitoneal TPM during index hospital stay, and (c) followed-up to evaluate treatment-related toxicity and response. The pharmacokinetics of TPM and paclitaxel in peritoneal fluid and systemic blood samples will be measured. Second dose of TPM is given in clinic if no disease progression or significant AEs.

This is a dose escalation study. Dose escalation will proceed using an accelerated titration design (ATD) with intra-patient dose escalation.

In the event either:

• 1 patient exhibits DLT during the first course of treatment or

• 2 patients exhibit grade 2 study drug-related (attribution of probable or definite) toxicity during the first course of treatment.

The design switches to a standard 3+3 design at the dose that triggered the switch-two additional patients are accrued at this dose level. Decisions on when and how to escalate if the design switches to a 3+3 are described in the protocol section 6.3 ;

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

• NCT number: NCT05159050
• Study type: Interventional
• Source: University of Iowa
• Contact: Carlos H.F. Chan, MD, PhD
• Phone: (319) 356-1727
• Email: carlos-chan@uiowa.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: April 26, 2022
• Completion date: November 2024