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5520 Background: Malignant ascites in ovarian carcinoma patients (pts.) is associated with a poor prognosis and reduced quality of life. Catumaxomab (anti-EpCAM × anti-CD3) is known to effectively eliminate tumor cells within ascites by simultaneously activating T cells and Fc gamma-receptor positive cells and redirecting them against the tumor. Methods: A total of 129 ovarian cancer pts. with recurrent symptomatic malignant ascites containing EpCAM+ tumor cells were enrolled in the study; 85 were randomized to treatment with catumaxomab (paracentesis plus intraperitoneal infusions of 10, 20, 50 and 150 μg for 11 days), and 44 to the control arm (paracentesis alone). The primary endpoint was puncture free survival (time to first need for paracentesis after treatment or time to death, which ever occurred first). Results: Pts. characteristics were well balanced in both arms. Median puncture free survival was 52 days for catumaxomab vs. 11 days for control (p No significant financial relationships to disclose.

5007 Background: The addition of further drugs to TC is regarded as an option for improving 1st-line therapy in OC. Anthracyclines have shown activity in OC and are among the drugs suitable for evaluation in triple drug regimens. Methods: We performed a randomized phase III trial in pts. with advanced OC stages FIGO IIB-IV to determine the role of epirubicin (E) when added to TC. Pts were randomized to receive 6 cycles of either T 175 mg/m2 3 h iv + C AUC 5 (according to Calvert formula) + E 60 mg/m2 iv (TEC) or TC at same doses, both regimens given every 3 weeks. Pts. were stratified per center and according to FIGO stage and post-operative residual tumor (RT): stratum I ‘FIGO IIB-IIIC and RT =/ 1 cm or FIGO IV’. Primary endpoint was overall survival (OS), secondary endpoints were progression-free survival (PFS), overall response (OR; complete + partial), toxicity, quality of life, and stratified analysis of OS. Results: From 11/97 to 2/00 1,282 pts. were randomi...

Address: 1Department of Obstetrics and Gynecology, University Hospital, Essen, Germany, 2Department of Obstetrics and Gynecology, University Hospital Munich/Grosshadern, Munich, Germany, 3Research Center for Oncology, Moscow, Russia, 4Department of Obstetrics and Gynecology, University Hospital Munich-City, Munich, Germany, 5Department of Gynecology, University Hospital Technical University, Munich, Germany, 6Department of Obstetrics and Gynecology, University Hospital, Kiel, Germany, 7Moscow Oncology Clinical Hospital, Moscow, Russia, 8Department of Surgery, University Hospital Munich/Grosshadern, Munich, Germany, 9Frauenklinik vom Roten Kreuz, Munich, Germany, 10Central Clinical Hospital of Ministry, Moscow, Russia, 11St. Petersburg Scientific Oncology Institute, St. Petersburg, Russia and 12Department of Gynecology and gynecological Oncology, Dr. Horst-Schmidt-Kliniken, Wiesbaden, Germany

5065 Background: Although CA125 kinetic profiles may be related with relapse risk in ovarian cancer patients treated with chemotherapy, no reliable kinetic parameters have been reported. Mathematic...