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

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Fresenius Biotech GmbH:

Enrollment:	258
Study Start Date:	September 2004
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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, Csanady 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, Strohlein MA, Jager 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.

Additional 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. Epub 2012 Jun 24.

ClinicalTrials.gov Identifier:	NCT00836654 History of Changes
Other Study ID Numbers:	60117
Study First Received:	February 3, 2009
Last Updated:	February 4, 2009
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Fresenius Biotech GmbH:

EpCAM positive tumor
malignant ascites
intraperitoneal

Additional relevant MeSH terms:

Ascites
Pathologic Processes
Antibodies, Bispecific

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013