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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

Phase 2
18 Years
Not Enrolling
Malignant Ascites

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Trial Information

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

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.

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 or ≤ 12 months after primary platinum-based systemic or IP
chemotherapy OR relapse following reinduction ≥ 12 months after primary chemotherapy.

- Have refused, failed, or have been deemed not suitable candidates for gemcitabine or
liposomal doxorubicin.

- 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 ascites 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Proportion of Patients Who Achieved at Least a 4-fold Increase of Puncture/Paracentesis-free Interval Following Catumaxomab Relative to Their Pre-treatment Interval.

Outcome Description:

The parameter to be estimated is the proportion of patients who achieve at least a 4-fold increase in their puncture/paracentesis-free interval. The pretreatment interval is defined as the length of time between the patient's most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jonathan Berek, MD MMSc

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University Hospital and Clinics, Department of Obstetrics and Gynecology


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

August 2010

Related Keywords:

  • Malignant Ascites
  • 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
  • Ascites
  • Ovarian Neoplasms



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Massachusetts General Hospital Boston, Massachusetts  02114-2617
Wayne State University Detroit, Michigan  48202
Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Miami Miami, Florida  33136
The Methodist Hospital Houston, Texas  77030
Johns Hopkins Medical Institute Baltimore, Maryland  21231
University of Arizona Cancer Center Tucson, Arizona  85724
Northern Indiana Cancer Research Consortium South Bend, Indiana  
University of Oklahoma Health Science Center Oklahoma City, Oklahoma  73104
Stanford University Hospital and Clinics Stanford, California  
Florida Hospital Cancer Center Orlando, Florida  
University of Louisville Cancer Center Louisville, Kentucky  
Dartmouth-Hitchock Medical Center Lebanon, New Hampshire  
Wake-Forest University Winston-Salem, North Carolina  
Magee Women's Hospital, University of Pittsburgh Pittsburgh, Pennsylvania  
University of San Diego La Jolla, California  
Columbia University Cancer center New York, New York