Catumaxomab as a Consolidation Therapy in Patients With Ovarian Cancer in Second or Third Clinical Disease Remission

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy and safety of catumaxomab as consolidation treatment in patients with epithelial ovarian cancer in second or third complete remission.

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

Details

• Lead Sponsor: Grupo Español de Investigación en Cáncer de Ovario
• Collaborator: Neovii Biotech
• Treatments: Antibodies, Bispecific; Catumaxomab

Criteria

Inclusion Criteria:

• Signed Informed consent.

• Initial histopathologic diagnosis of epithelial ovarian cancer, cancer of the fallopian tube or primary peritoneal carcinoma

• Women ≥ 18 years

• ECOG performance status ≤ 1 (Eastern Cooperative Oncology Groupperformance)

• Initial surgical cytoreduction as primary treatment combinated with Platinum- based chemotherapy administered as part of primary therapy.

Failure of the primary treatment as manifested by recurrent disease that have achieved a second or third complete response with a second or third-line chemotherapy (platinum-based or not).

The complete response to the second or third-line chemotherapy is defined as non symptoms of cancer persistence, normal CA-125 (cancer antigen 125), negative medical examination, and no evidence of disease in a TAC.

• At least 4 cycles of second or third-line chemotherapy must have been administered

• Surgery performed at first or second relapse in conjunction with second or third-line chemotherapy is permitted.

Exclusion Criteria:

• Acute or chronic infection

• Concomitant treatment with cancer chemo- and/or radiotherapy

• Exposure to an investigational product within 28 days of first infusion

• Previous treatment with murine monoclonal antibodies

• Inadequate renal function: creatinine >1.5 upper limit of normal [ULN] and/ or calculated creatinine clearance ≥ 50 mL/min

• Inadequate hepatic function (AST, ALT, >2.5 xULN; bilirubin >1.5 xULN), Hypoalbuminaemia < 3 g/dL

• Platelets <80000 cells/mm3; absolute neutrophil count (ANC) <1000 cells/mm3,

• Hb < 8g/dL and PTT > 2 x ULN

• Patients with occlusive intestinal or symptomatic sub-occlusive intestinal within the last 30 days.

• Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia

• Unable or unwilling to comply fully with the protocol.

• Any co-morbid disease that would increase risk of toxicity according to investigator judgment

• Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures

• Exposure to investigational product, cancer, chemo-or radiotherapy within the last 28 days (6 weeks for nitrosoureas or mitomycin C) before first infusion

• Known or suspected hypersensitivity to catumaxomab or similar antibodies

• Long-lasting steroid treatment (≥ 7 days), Patients should only be included after stepwise discontinuation and free of steroids for a minimum of 5 days