Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection
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|ClinicalTrials.gov Identifier: NCT00464893|
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : December 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Gastric Adenocarcinoma||Drug: Catumaxomab Drug: catumaxomab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2013|
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
- 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 ]
- frequency, relationship and seriousness of adverse events [ Time Frame: 30 days after last catumaxomab administration ]
- surgical resection rate [ Time Frame: after surgery ]
- chemotherapeutic response rate [ Time Frame: after neoadjuvant CTx ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464893
|Hamburg, Berlin, Heidelberg, Köln, Halle, Germany|
|Nottingham, United Kingdom|
|Principal Investigator:||Carsten Bokemeyer, Prof MD||University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany|