Intraperitoneal Paclitaxel for Patients with Primary Malignant Peritoneal Mesothelioma - a Phase I/II Dose Escalation and Safety Study

Recruiting

Conditions: asbestos cancer
Peritoneal mesothelioma
10027412

Registration Number: NL-OMON56619

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 21

Inclusion Criteria

• Histological confirmed diagnosis of malignant peritoneal mesothelioma •
Patients that are not eligible (or willing) to undergo cytoreductive surgery
(CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) • Age >= 18 years
old • Written informed consent according to the ICH-GCP and national/local
regulations • Patients must be ambulatory (WHO-ECOG performance status 0 or 1)
• Ability to return to the Erasmus MC for adequate follow-up as required by
this protocol • Patients must have normal organ function and adequate bone
marrow reserve as assessed by the following laboratory requirements; absolute
neutrophil count >1.5 * 10^9/l, platelet count >100*10^9/l and Hemoglobin
>6.0mmol /l. Patients must have a Bilirubin < 1* x upper limit of normal (ULN),
Serum AST and ALT < 2.5 x ULN

Exclusion Criteria

• Extra-abdominal disease/metastatic disease established by preoperative
CT-scan of thorax-abdomen and/or PET-scan. Imaging not older than two months at
time of surgery
• Medical or psychological impediment to probable compliance with the protocol
• Serious concomitant disease or active infections
• History of auto-immune disease or organ allografts, or with active or chronic
infection, including HIV and viral hepatitis
• Serious intercurrent chronic or acute illness such as pulmonary (COPD or
asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness
considered by the study coordinator to constitute an unwarranted high risk for
participation in this study
• Pregnant or lactating women; for all women of child-bearing potential a
negative urine pregnancy test will be required as well as the willingness to
use adequate contraception during the study until 4 weeks after finishing
treatment
• Absence of assurance of compliance with the protocol
• An organic brain syndrome or other significant psychiatric abnormality which
would comprise the ability to give informed consent, and preclude participation
in the full protocol and follow-up

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is to determine the maximum tolerable dose<br /><br>(MTD) of intraperitoneal (IP) paclitaxel monotherapy, for patients with<br /><br>malignant peritoneal mesothelioma (MPM) who are not eligible to undergo<br /><br>CRS-HIPEC. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Safety: toxicity assessment according to CTCAE version 5.0<br /><br>- Feasibility: the treatment will be considered feasible if at least 50% of<br /><br>patients are able to finish 75% (i.e. 6) of total planned cycles (i.e. 8).<br /><br>- Pharmacokinetic profile: intraperitoneal and systemic pharmacokinetic<br /><br>measurements will be obtained during the first and fourth treatment cycle, at<br /><br>time points prior to infusion, at the end of peritoneal infusion as well as<br /><br>every hour up to patients discharge. </p><br>