COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00836654
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : February 5, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast) Malignant Ascites Biological: Catumaxomab (Removab) Procedure: paracentesis Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group
Study Start Date : September 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Arm Intervention/treatment
Active Comparator: 1 Catumaxomab
Patient received Catumaxomab and paracentesis
Biological: Catumaxomab (Removab)
Puncture free survival
Other Name: Removab

Procedure: paracentesis
No Intervention: 2:
Patient treated by paracentesis alone, but after the second paracentesis the patient is able to cross-over in the Catumaxomab-arm

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00836654    
Other Study ID Numbers: 60117
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009
Keywords provided by Neovii Biotech:
EpCAM positive tumor
malignant ascites
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes
Gastrointestinal Agents