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Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma

NCT05449366 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

  • Peritoneal Malignant Mesothelioma

Interventions

DRUG

Intraperitoneal Paclitaxel Solution (Ml)

Weekly cycles of intraperitoneal paclitaxel monotherapy

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449366 on ClinicalTrials.gov