Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Single-arm, Phase II Study of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intra- and Postoperatively in Patients With Epithelial Ovarian Cancer|
- the rate of all specific postoperative complications newly observed during a period of 30 days after surgery [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
- safety and efficacy endpoints [ Time Frame: EOS is on day 30, post study period additional 23 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
An open label, multi-center, single-arm, phase II study according to Fleming´s one-stage design. The surgical procedure on Day 0 will be performed according to AGO State of the Art, followed by one intraoperative and four postoperative intraperitoneal administrations of catumaxomab within 16 days. The Discharge Visit will be performed when the patient is leaving the hospital but not earlier than 1 day after the last infustion, followed by the End of Study Visit on Day 30.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.