Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
This study is currently recruiting participants.
Verified by Fresenius Biotech GmbH, March 2008
Sponsors and Collaborators: Fresenius Biotech GmbH
Fresenius Biotech North America
Information provided by: Fresenius Biotech GmbH
ClinicalTrials.gov Identifier: NCT00326885
  Purpose

The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.


Condition Intervention Phase
Ovarian Neoplasms
Ascites
Drug: catumaxomab
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Immunoglobulins Globulin, Immune Visilizumab Catumaxomab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Single-Arm, Open-Label, Phase II Study to Assess the Safety and Efficacy of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intraperitoneally in Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

Further study details as provided by Fresenius Biotech GmbH:

Primary Outcome Measures:
  • paracentesis-free interval post-treatment compared to pre-treatment interval

Secondary Outcome Measures:
  • clinical benefit by evaluation of ascites-related signs and symptoms
  • safety and tolerability

Estimated Enrollment: 35
Study Start Date: June 2006
Detailed Description:

A multi-center, phase II study of catumaxomab in ovarian cancer patients with recurrent symptomatic malignant ascites requiring therapeutic paracentesis. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 7 months (includes the baseline therapeutic paracentesis and screening period, 11 to 21 days treatment period, and up to 180 days/6 months follow-up), with monthly post-study follow-up for the lifetime of the patient.

Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent
  • Histologically confirmed diagnosis of epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer; any stage at diagnosis [International Federation of Gynecology and Obstetrics (FIGO) Stages I through IV].
  • Progression on primary platinum-based systemic chemotherapy or progression after at least 2 chemotherapy regimens
  • Recurrent symptomatic malignant ascites requiring therapeutic paracentesis
  • At least 1 therapeutic paracentesis within 4 weeks prior to baseline paracentesis
  • Age ≥ 18 years
  • ECOG performance status of 0, 1, or 2
  • Life expectancy ≥ 16 weeks
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, and total bilirubin ≤ 1.5 x ULN
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3 and platelet count ≥ 75,000/mm3
  • Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility).
  • Willingness of patients of childbearing potential to use an effective contraceptive method (i.e., oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion.

Exclusion Criteria:

  • Acute or chronic systemic infection
  • Exposure to investigational drugs, chemotherapy or radiotherapy 21 days prior to the first dose of catumaxomab
  • Major surgery 2 weeks prior to first dose
  • Previous treatment with mouse or rat antibodies
  • Known or suspected hypersensitivity to catumaxomab or other monoclonal antibodies
  • Body mass index (BMI) < 19 (body weight after paracentesis to be used for calculation of BMI)
  • Serum albumin level < 2.0 g/dL
  • Reduced nutritional status requiring predominantly parenteral nutrition (> 50% of energy intake). Permanent naso-gastric (NG) feeding tube.
  • Ileus in a location that precludes paracentesis
  • Extensive liver metastases (> 70% organ volume comprises malignancy)
  • Documented brain metastases
  • History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia 3 months prior to the first dose of catumaxomab
  • Portal vein obstruction or portal vein thrombosis diagnosed by computed tomography (CT) scan at screening
  • Persistent massive pleural effusion or inadequate respiratory function of any other etiology (except if related to ascite symptoms) in the opinion of the investigator
  • Any other condition which, according to the investigator, results in an undue risk to the patient by participating in the study
  • Prior exposure to catumaxomab
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326885

Contacts
Contact: Aaron Enke 1-866-491-8137 clinicaltrials@fresenius-biotech.com

Locations
United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, California
Stanford University Hospital and Clinics Recruiting
Stanford, California, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
University of California Recruiting
San Diego, California, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, Florida
Florida Hospital Cancer Center Recruiting
Orlando, Florida, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, Indiana
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, Kentucky
University of Louisville Cancer Center Recruiting
Louisville, Kentucky, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, Maryland
Johns Hopkins Medical Institute Not yet recruiting
Baltimore, Maryland, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, New Hampshire
Dartmouth-Hitchock Medical Center Recruiting
Lebanon, New Hampshire, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, North Carolina
Wake-Forest University Recruiting
Winston-Salem, North Carolina, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, Oklahoma
University of Oklahoma Health Science Center Recruiting
Oklahoma City, Oklahoma, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, Pennsylvania
Magee Women's Hospital, University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States
Contact     866-491-8137     clinicaltrials@fresenius-biotech.com    
Sponsors and Collaborators
Fresenius Biotech GmbH
Fresenius Biotech North America
Investigators
Study Chair: Jonathan Berek, MD MMSc Stanford University Hospital and Clinics, Department of Obstetrics and Gynecology
  More Information

Publications:
Study ID Numbers: IP-REM-AC-02-US
Study First Received: May 15, 2006
Last Updated: March 14, 2008
ClinicalTrials.gov Identifier: NCT00326885  
Health Authority: United States: Food and Drug Administration

Keywords provided by Fresenius Biotech GmbH:
Ascites
Epithelial Cancer
Epithelial Carcinoma
Epithelial Ovarian Cancer
Epithelial Ovarian Carcinoma
Fallopian Tube Cancer
Fallopian Tube Carcinoma
Malignant Ascites
Ovarian Cancer
Ovarian Carcinoma
Ovarian Epithelial Cancer
Ovarian Epithelial Carcinoma
Peritoneal Cancer
Peritoneal Carcinoma
Recurrent Ascites
Recurrent Malignant Ascites
Recurrent Symptomatic Malignant Ascites
Symptomatic Malignant Ascites
Symptomatic Ascites
Malignant ascites
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Fallopian Tube Neoplasms
Recurrence
Carcinoma
Genital Diseases, Female
Antibodies
Ascites
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Immunoglobulins
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Pathologic Processes
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009