epithelial cell adhesion molecule (EpCAM) expressing tumors in patients with malignant ascites requiring therapeutic ascites puncture MedDRA version: 9.1 Level: LLT Classification code 10025538
Conditions
Sponsors
Fresenius Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent, 2. Histologically confirmed diagnosis of cancer, 3. Malignant ascites requiring peritoneal puncture, 4. EpCAM positive tumor cells in the ascites fluid, 5. Age: >/= 18 years, 6. Karnofsky Index >/= 60, 7. Negative pregnancy test at screening in women with childbearing potential, 8. Life expectancy >8 weeks, 9. Patients who are refractory/resistant to chemotherapy or where the standard chemotherapy is no longer feasible Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acute or chronic infections, 2. Exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days (6 weeks for nitrosoureas or mitomycin C) before first infusion, 3. Previous treatment with mouse or rat monoclonal antibodies, 4. Known or suspected hypersensitivity to catumaxomab or similar antibodies, 5. Inadequate renal function (creatinine >1.5 ´ upper limit of normal [ULN]), 6. Inadequate hepatic function (aspartate aminotransferase, alanine aminotransferase, gamma?glutamyltransferase ³5 ´ ULN; bilirubin >1.5 ´ ULN), 7. Platelets 50% of energy intake), 11. Patients with gastric or small bowel feeding tube at study entry, 12. Patients with ileus within the last 30 days, 13. Known brain metastases in cancer history, 14. Patients with any other severe disease that would render a participation in the study an undue risk, 15. History of myocardial infarction, 16. Signs or symptoms of relevant cardiovascular disease, congestive heart failure or relevant cardiac arrhythmia (New York Heart Association [NYHA] class >II, for definition see Attachment 4), 17. History of cerebrovascular accident 18. Pregnant or nursing women, or women with childbearing potential and males who are not using an effective contraceptive method during the study and at least 3 months after the last infusion, 19. Patients with portal vein obstruction or portal vein thrombosis diagnosed by CT-scan at screening, 20. Patients with extensive liver metastases (>70% of the liver is metastasized), 21. Inadequate respiratory function in the opinion of the investigator, 22. Supposition that patient is not able or willing to comply with the requirements of the study, 23. Any further condition which according to the investigator results in an undue risk of the patient by participating in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Determination of systemic exposure of catumaxomab during and after four intraperitoneal infusions with increasing doses - Characterization of pharmacokinetics of catumaxomab after the second, the third and the fourth intraperitoneal infusion;Secondary Objective: - Characterization of cytokine levels after intraperitoneal administration of catumaxomab· Assessment of safety and tolerability of catumaxomab - Evaluation of efficacy of catumaxomab;Primary end point(s): - Determination of systemic exposure of catumaxomab during and after four intraperitoneal infusions with increasing doses - Characterization of pharmacokinetics of catumaxomab after the second, the third and the fourth intraperitoneal infusion | — |
Countries
Germany
Outcome results
None listed