Two-arm, randomized, open-label, phase IIIb study investigating the safety of a 3 hour i.p. infusion of catumaxomab with and without prednisolone premedication in patients with malignant ascites due to epithelial cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

Inclusion Criteria

Patients will be enrolled in this study only if they meet all of the following criteria:
•Signed and dated informed consent,
•Age: =18 years,
•Karnofsky index =60%,
•Histological confirmed diagnosis of epithelial cancer,
•Patients with malignant ascites requiring therapeutic ascites paracentesis,
•Patients where standard therapy is not available or no longer feasible,
•Life expectancy >12 weeks,
•BMI between 17 and 40kg/m2; prior to calculation of BMI reduce body weight by weight of current estimated ascites volume (exploratory value is sufficient)
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

Patients will not be enrolled in this study if they meet any of the following criteria:
•Documented acute or chronic infection,
•Concomitant treatment with other investigational product, cancer chemo-, or radiotherapy,
•In cases of previous exposure to investigational product, cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastasis) patients must be excluded if not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen). Patients must not have been exposed to nitrosoureas or mitomycin C within 6 weeks prior to the first infusion of catumaxomab.
•Previous treatment with entirely murine monoclonal antibodies
•Known or suspected hypersensitivity to catumaxomab or similar antibodies,
•Long-lasting steroid treatment (= 7 days), Patients should only be included after stepwise discontinuation and free of steroids for a minimum of 5 days
•Inadequate respiratory function, including symptomatic pleural effusion,
•Inadequate renal function (creatinine >1.5 x upper limit of normal [ULN],
•Inadequate hepatic function (aspartate aminotransferase, (AST), alanine aminotransferase (ALT) >5x ULN; bilirubin >1.5ULN)
•Platelets <80000 cells/mm3; absolute neutrophil count (ANC) <1500 cells/mm3,
•Albumin: lower than 3 g/dL or total protein < 6 g/dL
•Partial thromboplastin time (PTT) >2 x ULN
•Hemoglobin <8g/dL,
•Patients requiring entirely parenteral nutrition,
•Patients with ileus or with symptomatic subileus within the last 30 days,
•Signs or symptoms of relevant cardiovascular disease, congestive heart failure or cardiac arrhythmias (New York Heart Association [NYHA] class >II),
•Liver metastases with volume >70% of liver metastasized tissue,
•Known portal vein obstruction,
•Known brain metastases,
•Pregnant (as evidenced by positive pregnancy test at screening), or nursing women or women of childbearing potential and men who are not using an effective contraceptive method during the study and at least 3 months after the last infusion,
•Unable or unwilling to comply fully with the protocol,
•Patients with any other severe disease that would render a participation in the study an undue risk according to judgment of investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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