asbestos cancer Peritoneal mesothelioma
Conditions
Interventions
Patiënts undergo a diagnostic laparoscopy (DLS) according to standard work-up
for CRS-HIPEC. If the disease is considered not resectable, a peritoneal PAC
will be placed during DLS. Through this PAC
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety: toxicity assessment according to CTCAE version 5.0 - Feasibility: the treatment will be considered feasible if at least 50% of patients are able to finish 75% (i.e. 6) of total planned cycles (i.e. 8). - Pharmacokinetic profile: intraperitoneal and systemic pharmacokinetic measurements will be obtained during the first and fourth treatment cycle, at time points prior to infusion, at the end of peritoneal infusion as well as every hour up to patients discharge. | — |
Countries
Netherlands
Outcome results
None listed