Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: catumaxomab
Intervention description: Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).
Intervention MeSH terms: Catumaxomab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epithelial Cancer; Epithelial Carcinoma; Epithelial Ovarian Cancer; Epithelial Ovarian Carcinoma; Fallopian Tube Cancer; Fallopian Tube Carcinoma; Ovarian Cancer; Ovarian Carcinoma; Ovarian Epithelial Cancer; Ovarian Epithelial Carcinoma; Peritoneal Cancer; Peritoneal Carcinoma; Advanced Epithelial Ovarian Cancer

Summary:

      The purpose of this study is to determine whether the investigational drug catumaxomab
      delivered in the planned treatment schedule is a safe and effective treatment for women with
      advanced ovarian cancer who experience a complete response to chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent form before any protocol-specific screening
             procedures

          -  Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or
             primary peritoneal cancer, Fédération Internationale de Gynécologie et d'Obstétrique
             (FIGO) stage IIb - IV

          -  Optimal or sub-optimal cytoreductive surgery

          -  Clinical complete response to platinum and taxane-based therapy consisting of at least
             four cycles, based on computed tomography (CT) scan and a CA-125 (cancer antigen 125)
             level below 35 U/mL

          -  Age ≥18 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Last dose of platinum and taxane-based therapy completed within 6 weeks prior to the
             start of catumaxomab treatment

          -  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 chemotherapy, radiotherapy, immunotherapy or investigational anti-cancer
             therapy within 6 weeks of first dose of catumaxomab other than last regimen of
             platinum and taxane chemotherapy as outlined in protocol

          -  Known human immunodeficiency virus (HIV) infection

          -  Previous treatment with non-humanized murine (rat or mouse) monoclonal antibodies
             (mAb)

          -  Inadequate renal function (creatinine > 1.5 x upper limit of normal [ULN])

          -  Inadequate hepatic function:

               -  Alanine aminotransferase (ALT) > 2.5 x ULN or

               -  Aspartate aminotransferase (AST) > 2.5 x ULN or

               -  Bilirubin > 1.5 x ULN

          -  Platelets < 100,000 cells/mm^3

          -  Absolute neutrophil count (ANC) < 1,500 cells/mm^3

          -  History of myocardial infarction, congestive heart failure or relevant cardiac
             arrhythmia within the last 6 months

          -  No other malignancy within the past 5 years except non-melanoma skin cancer or
             carcinoma in situ of the cervix if adequately treated

          -  No history of brain metastases

          -  Any further condition or disease that would, in the opinion of the Investigator,
             expose the patient to undue risk