Catumaxomab and prednisolone in patients with malignant ascites

• Research type

  Research Study

• Full title

  Two-arm, randomized, open-label, phase IIIb study investigating the safety of a 3 hour i.p. infusion of catumaxomab with and without prednisolone premedication in patients with malignant ascites due to epithelial cancer

• IRAS ID

  21465

• Contact name

  MD Simon Leslie Parsons

• Sponsor organisation

  Fresenius Biotech GmbH

• Eudract number

  2008-001557-17

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00822809

• Research summary

  Catumaxomab is a novel antibody based therapy which previous clinical trials have shown, provides a clinically relevant benefit to patients with malignant ascites. Based on the results of a pivotal phase II/III trail (IP-REM-AC-01) the use of a 6 hour intraperitoneal infusion of Catumaxomab for the treatment of malignant ascites has been submitted for commercial approval. Although effective, treatment with Catumaxomab results in frequent cases of nausea, vomiting, fever, and abdominal pain. This study aims to investigate whether these side effects can be controlled by pre-treatment with prednisolone without affecting the efficacy of the treatment. The present study also proposes to investigate administration using a shorter three hour infusion which would be more convenient to both patients and hospital staff. This is a randomised, open label study in which 156 patients who have malignant ascites will be recruited at centres in 12 EU countries (Austria, Belgium, Denmark, France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, Switzerland, UK) and randomly assigned (1:1) for treatment with Catumaxomab alone or with prednisolone premedication. Asciteflud will be drained prior to each infusion and all patients will receive 4 escalating doses of Catumaxomab administered as 3 hour intraperitoneal infusions via an in dwelling catheter over a 10 day treatment period (10æg day 0, 20æg day 3, 50æg day 7, 150æg day 10). The primary endpoint of the study will be the assessment of Catumaxomab related adverse reactions based on a composite safety score calculated from occurrences of fever, nausea, vomiting and abdominal pain during the study period. Efficacy of the treatment will be measured as, the time until the first need for therapeutic ascites drainage (puncture) following the last infusion, and mean puncture-free survival, as well as via quality of life and ascites symptoms assessment questionnaires. The study is sponsored by Fresenius Biotech.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  09/H0402/87

• Date of REC Opinion

  11 Sep 2009

• REC opinion

  Further Information Favourable Opinion