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

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ClinicalTrials.gov Identifier: NCT00836654
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : February 5, 2009
Sponsor:
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

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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




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

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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00836654     History of Changes
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
intraperitoneal
Additional relevant MeSH terms:
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Ascites
Pathologic Processes
Catumaxomab
Antibodies, Bispecific
Gastrointestinal Agents
Immunologic Factors
Physiological Effects of Drugs