Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neovii Biotech
• Treatments: Antibodies; Antibodies, Bispecific; Catumaxomab; Immunoglobulins

Criteria

Inclusion Criteria:

• signed and dated informed consent form before any protocol-specific screening procedures

• patients has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (FIGO IA(G2-G3) - IV)

• Karnofsky index > or equal 70

• female at an age of 18 years or older

• negative pregnancy test

Exclusion Criteria:

• exposure to prior cancer therapy specific for ovarian cancer

• previos treatment with non-humanized mouse or rat monoclonal antibodies

• known / suspected hypersensitivity to catumaxomab or similar antibodies

• second malignangcy within the last 5 years

• presence of constant immunosuppressive therapy

• presence of symptomatic heart failure or occlusive arterial diseases

• inadequate renal or hepatic function

• presence of any acute or chronic systemic infection