Trials Sponsors Conditions Drugs Pricing

Conditions

Patients with malignant peritoneal mesothelioma Peritoneal Malignant Mesothelioma

Keywords

Intraperitoneal chemotherapyPaclitaxelSystemic chemotherapyPalliative treatmentDose-escalation study

Outcome Measures

Primary Outcomes (1)

The maximum tolerable dose (MTD)
The primary endpoint of the study is to determine the maximum tolerable dose (MTD) of intraperitoneal (IP) paclitaxel monotherapy, for patients with malignant peritoneal mesothelioma (MPM) who are not eligible to undergo CRS-HIPEC.
Week 3 (after two completed cycles of therapy, each cycle is 1 week)

Secondary Outcomes (5)

Toxicity assessment
Week 3 (after two completed cycles of therapy, each cycle is 1 week)
Feasibility determined by the number of cycles given
Week 8 (after eight completed cycles of therapy, each cycle is 1 week)
Area Under the Curve (AUC)
At cycle 1 and 4 (each cycle is 1 week)
Maximum concentration (Cmax)
At cycle 1 and 4 (each cycle is 1 week)
Elimination half life (t1/2)
At cycle 1 and 4 (each cycle is 1 week)

Study Arms (1)

Treatment arm

EXPERIMENTAL

According to standard of care work-up for CRS-HIPEC, patients will undergo diagnostic laparoscopy to determine the feasibility of complete cytoreduction with HIPEC. In case CRS-HIPEC is not considered feasible, a peritoneal port-a-cath (PAC) system will be placed. Through this PAC, 8-16 weekly cycles of intraperitoneal chemotherapy will be administered.

Drug: Intraperitoneal Paclitaxel Solution (Ml)

Interventions

Intraperitoneal Paclitaxel Solution (Ml)Drug

Weekly cycles of intraperitoneal paclitaxel monotherapy

Also known as: Paclitaxel

Treatment arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histological confirmed diagnosis of malignant peritoneal mesothelioma
Patients that are not eligible (or willing) to undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC)

Sponsors & Collaborators

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Type not reportedlead
Erasmus Medical Center
Otherlead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3000 CA, Netherlands

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator (MD PhD)

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 8, 2022

Study Start

February 1, 2022

Actual (reported)

Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Treatment arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Treatment arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations