Epithelial Ovarian Cancer MedDRA version: 9.1 Level: LLT Classification code 10033162 Term: Ovarian epithelial cancer stage II MedDRA version: 9.1 Level: LLT Classification code 10033163 Term: Ovarian epithelial cancer stage III MedDRA version: 9.1 Level: LLT Classification code 10033164 Term: Ovarian epithelial cancer stage IV MedDRA version: 9.1 Level: LLT Classification code 10033161 Term: Ovarian epithelial cancer stage I
Conditions
Interventions
Product Name: catumaxomab (INN)
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Fresenius Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the safety of an adjuvant treatment with catumaxomab in patients with epithelial ovarian cancer in terms of post-operative complication rate.;Secondary Objective: Determination of further safety data within the study period as well as efficacy data collected during post study follow-up. ;Primary end point(s): The primary endpoint is the rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least one dose of catumaxomab. The events below will be regarded as specific postoperative complications: • Surgical untoward event o Any fistula o Ileus requiring any surgical therapy o Bowel perforation o Anastomosis insufficiency requiring surgery o Wound infection o Hemorrhage requiring any therapy o Septicemia • Non-surgical untoward event o Thromboembolism verified by at least one of the following objective diagnostic measures: - Positive V/Q scan (“high probability” according to PIOPED-criteria) - Angiography - CT-scan o Infection = CTC Grade 3 o Pleural effusion requiring puncture o Renal insufficiency = CTC Grade 3 o Liver failure = CTC Grade 3 o Heart rhythm disorder requiring intervention o Neurological disorder = CTC Grade 3 o Pulmonary edema • Death, as an outcome of an event with fatal result With regard to postoperative complications a study specific DSMB will evaluate all patients in a timely manner, as there is a significant frequency of complications due to the surgical procedure alone. The DSMB will be organised by sponsor's Drug Safety and Pharmacovigilance Department, similar to the general catumaxomab DSMB using the same procedures and workflows. | — |
Countries
Austria, Germany
Outcome results
None listed