drugset / Trial / NCT05449366

Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma

NCT05449366 ↗

Phase 1/2 Completed 7 enrolled Erasmus Medical Center
NaSingle-groupOpen-labelTreatment

Summary

Patients primary malignant peritoneal mesothelioma (MPM), without extra-abdominal disease, that are not eligible (or willing) to undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) can be included in this study. Patients will be treated with intraperitoneal (IP) chemotherapy (paclitaxel) in weekly cycles. The primary aim of this study is to determine the maximum tolerable dose (MTD) of IP monotherapy with paclitaxel for patients with MPM. The secondary aims are to assess safety and feasibility of this strategy, and to study the pharmacokinetics of paclitaxel in this setting.

Timeline

Start
2022-02-01
Primary completion
2025-06-01
Completion
2025-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule — Intrathecal