Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Open-label Phase II Study to Evaluate the Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients With Gastric Adenocarcinoma After Neoadjuvant Chemotherapy and Intended Curative Resection|
- rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab [ Time Frame: 30 days after last catumaxomab administration ] [ Designated as safety issue: Yes ]
- frequency, relationship and seriousness of adverse events [ Time Frame: 30 days after last catumaxomab administration ] [ Designated as safety issue: Yes ]
- surgical resection rate [ Time Frame: after surgery ] [ Designated as safety issue: No ]
- chemotherapeutic response rate [ Time Frame: after neoadjuvant CTx ] [ Designated as safety issue: No ]
- overall survival at 3, 6, 9, 12 and 24 month after EOT, defined as the time from study enrolment until death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- disease-free survival at 3, 6, 9, 12 18 and 24 months after EOT, defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||July 2013|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Active Comparator: catumaxomab arm
Patients will get first the chemotherapeutic regimen (Epirubicin, Cisplatin and Capecitabine or 5-Fluorouracil) consisting of three 21-day cycles, starting on the weeks 1, 4 and 7. Four weeks after CTx the D2 surgery will take place. Treatment with catumaxomab will consist of an initial dose of 10µg given intraoperatively as in intraperitoneal bolus and of four postoperative ascending doses.
10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
Other Name: RemovabDrug: catumaxomab
10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg
Other Name: Removab
An open-label, multi-center phase II study in surgically resectable patients after neoadjuvant ECX-chemotherapy, with confirmed diagnosis of gastric adenocarcinoma and with a high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy.
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus and of four postoperative ascending doses (10-20-50-150 µg)which will be administered as an i.p.-infusion using an installed abdominal i.p.-port on the postoperative days 7, 10, 13 and 16.
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.
|Hamburg, Berlin, Heidelberg, Köln, Halle, Germany|
|Nottingham, United Kingdom|
|Principal Investigator:||Carsten Bokemeyer, Prof MD||University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany|