Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group
Phase 2
Completed
- Conditions
- EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast)Malignant Ascites
- Interventions
- Biological: Catumaxomab (Removab)Procedure: paracentesis
- Registration Number
- NCT00836654
- Lead Sponsor
- Neovii Biotech
- Brief Summary
The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 258
Inclusion Criteria
- histological confirmed diagnosis cancer
- symptomatic malignant ascites
- EpCAM positive tumor
- EOCG 0-2
- negative pregnancy
Exclusion Criteria
- acute or chronic infection
- exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days
- previous treatment with mouse monoclonal antibodies
- known or suspected hypersensitivity to Removab or similar antibodies
- inadequate renal function
- inadequate hepatic function (AST, ALt, GTP,< x ULN; bilirubin <1.5xULN)
- Platelets > 80000 cells/mm3; absolute neutrophil count (ANC) < 1500 cells/mm3
- BMI < 17
- Patients with reduced nutritional status
- Ileus within the last 30 days
- Brain metastases in cancer history
- Pregnant and nursing women
- history of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within previous 3 months
- inadequate respiratory function in option of investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Catumaxomab Catumaxomab (Removab) Patient received Catumaxomab and paracentesis 1 Catumaxomab paracentesis Patient received Catumaxomab and paracentesis
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method