NCT05449366CompletedPhase 1/2
Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma
Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma - a Phase I/II Dose Escalation and Safety Study
Source: ClinicalTrials.gov · Last updated 2 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 22 Jun 2022
- Start date
- 1 Feb 2022
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Mesothelioma
- NCT number
- NCT05449366
- EU CT number
- 2024-516738-36-00
- EudraCT number
- 2021-003637-11
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 7
- From 1 Feb 2022 to the primary completion date, 1 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious concomitant disease or active infections
Other illness
- 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
- 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
Age
- 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
Other
- Medical or psychological impediment to probable compliance with the protocol
- 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
Who the study is looking for
- 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 International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and national/local regulations
- Patients must be ambulatory, i.e. World Health Organization-Eastern Cooperative Oncology Group (WHO-ECOG) performance status 0 or 1
- Ability to return to the Erasmus Medical Center 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 \<1½ x upper limit of normal (ULN), Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 x ULN
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Completed |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.