NCT02611037

Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma

A Phase 2 Study of Transarterial Chemoperfusion Treatment With Cisplatin, Methotrexate and Gemcitabine in Patients With Unresectable Pleural Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant pleural mesothelioma (MPM).

Detailed description

This is an open-label, single arm, phase 2 study with a lead in safety cohort to evaluate the safety and efficacy of transarterial chemoperfusion treatment with cisplatin (35 mg/m2\^), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2) in patients with unresectable MPM. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2) and regular doses of cisplatin (35 mg/m\^2 body surface area (BSA)) and gemcitabine (1000 mg/m\^2 BSA).

Conditions

• Malignant Pleural Mesothelioma
• Mesothelioma

Interventions

Type	Name	Description
DRUG	Cisplatin	The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin.
DRUG	Methotrexate	The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2).
DRUG	Gemcitabine	The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine.
OTHER	Lung Cancer Symptom Scale for Mesothelioma Questionnaire	Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.

Timeline

• Start date: 2016-03-04
• Primary completion: 2021-10-16
• Completion: 2024-01-26
• First posted: 2015-11-20
• Last updated: 2025-12-18
• Results posted: 2023-02-01

Locations

1 site across 1 country: United States