Multicenter, single-arm, phase II study of the tri functional antibody catumaxomab (anti EpCAM x anti-CD3) administered intra- and postoperatively in patients with epithelial ovarian cancer - n.a.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1.Signed and dated informed consent form before any protocol-specific screening
procedures
2.Patient has a primary diagnosis of an epithelial ovarian cancer including clear cell
carcinoma (FIGO IA(G2-G3) – IV) (histologically confirmed)
3.Karnofsky index > = 70
4.Female at an age of 18 years or older
5.Negative pregnancy test result at screening in women of childbearing potential
(applies to patients without documented menopause or sterility)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Exposure to prior cancer therapy (surgery, investigational product-, chemo- or
radio-therapy) specific for ovarian cancer
2.Previous treatment with non-humanized mouse or rat monoclonal antibodies
3.Known/suspected hypersensitivity to catumaxomab or similar antibodies
4.Second malignancy within the last 5 years (if directly influencing patient's overall
prognosis)
5.Presence of constant immunosuppressive therapy
6.Presence of symptomatic heart failure or occlusive arterial diseases
7.Inadequate renal function (creatinine >1.5 x ULN)
8.Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin = 1.5 x ULN)
9.Platelets <100.000 cells/mm3; absolute neutrophil count <1500 cells/mm3
10.Presence of any acute or chronic systemic infection
11.Presence of complete bowel obstruction
12.Presence of symptomatic brain metastases
13.Inadequate respiratory function in the opinion of the investigator
14.Any further condition which, according to the opinion of the investigator, results
in an undue risk of the patient by participating in the present study
15.Parallel participation in another clinical trial or previous participation in this study
16.Pregnant or nursing women, or women with childbearing potential who are not
using an effective contraceptive method during the study and for at least 3
months after the last infusion

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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