feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy in patients with recurrent ovarian cancer

Conditions: Recurrent Epithelial Ovarian Cancer

Summary: 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.


Eligibility criteria:
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

Keywords: recurrent epithelial ovarian cancer