Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer

Single -Arm, Multicenter Phase-II Trial for Catumaxomab and Chemotherapy in Patients With Recurrent Ovarian Cancer to Investigate the Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy Regimes

Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes.

Inclusion Criteria:

• Histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer
• Recurrent ovarian cancer disease
• Signs for progression either measurable disease according to RECIST or CA 125 increase according the GCIG-criteria or clinical symptoms of tumor progression according to RECIST
• Radiologically and cytologically confirmed malignant ascites possible to puncture
• Life expectancy ≥ 12 weeks
• Age ≥ 18 years
• ECOG performance status at least 1
• No prior operation or, in case of prior operation, the patient must be recovered therefrom. The operation must be performed at least 4 weeks prior to start of study drug
• Capable of understanding the purposes and risks of the study, willing and able to participate in the study, and written informed consent
• Non-childbearing potential or negative pregnancy test

Exclusion Criteria:

• known brain metastases
• Concomitant cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastases)
• Any investigational product within 2 weeks prior to first administration of catumaxomab
• In cases of previous exposure to investigational product, cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis):

not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in-/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen)

• Patients must not have been exposed to nitrosoureas or mitomycin C within 6 weeks prior the first infusion of catumaxomab
• Abnormal organ or bone marrow function
• Use of immune-suppressive agents for the past 4 weeks prior to first administration of catumaxomab. For regular use of systemic corticosteroids patients should only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days prior to study entry
• Any known active and chronic infection
• Known HIV infection and / or hepatitis B virus or hepatitis C virus
• Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator
• Known or suspected hypersensitivity to catumaxomab and its analogues in general or to murine proteins (from rat or mouse)
• Known or suspected hypersensitivity to PLD, topotecan, paclitaxel, gemcitabine or their excipients.
• Patients with congestive heart failure New York Heart Association (NYHA) Class III and IV. Cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter bundle brunch block)or other signs and symptoms of relevant cardiovascular disease
• Body mass index (BMI) < 17 (assessment after ascites drainage)
• Inadequate respiratory function in the opinion of the investigator
• Presence of complete bowel obstruction
• Patients with substance abuse, medical or psychological or social conditions which the investigator believes would preclude compliance with the study requirements.
• Unwilling or unable to follow protocol requirements
• Participation in another clinical study with experimental therapy within 14 days before start of treatment
• Legal incapacity or limited legal capacity
• Subjects housed in an institution on official or legal orders
• Pregnancy or lactation period