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

Study Description

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

Study Design

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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

Arms and Interventions

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

Outcome Measures

Eligibility Criteria

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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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34.

Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7.

Zeidler R, Mysliwietz J, Csánady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6.

Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.

Heiss MM, Ströhlein MA, Jäger M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wimberger P, Gilet H, Gonschior AK, Heiss MM, Moehler M, Oskay-Oezcelik G, Al-Batran SE, Schmalfeldt B, Schmittel A, Schulze E, Parsons SL. Deterioration in quality of life (QoL) in patients with malignant ascites: results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone. Ann Oncol. 2012 Aug;23(8):1979-85. doi: 10.1093/annonc/mds178. Epub 2012 Jun 24.

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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

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