Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
Condition: Malignant Ascites
MeSH terms: Ascites
Intervention: catumaxomab
Intervention description: Catumaxomab is administered intraperitoneally via an indwelling catheter (or port) as a 3-hour infusion 4 times (Days 0, 3, 7, and 10) in ascending doses (10 mcg, 20 mcg, 50 mcg, and 150 mcg, respectively).
Intervention MeSH terms: Catumaxomab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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; Neoplasms, Glandular and Epithelial; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Summary:

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

Eligibility 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 or ≤ 12 months after primary platinum-based systemic or intraperitoneal
             (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

          -  Eastern Cooperative Oncology Group (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