Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00352833|
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : October 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Gastric Adenocarcinoma||Drug: catumaxomab||Phase 2|
A controlled, randomized, open-label, multi-center, parallel-group, Phase II study to generate valid hypotheses on safety and efficacy issues in patients with a primary confirmed diagnosis of gastric adenocarcinoma and a high risk of disseminated tumor cells due to serosal infiltration after curative gastrectomy. Eligible patients will be centrally randomized by IVRS during operation to one of the two study groups in an 1:1 ratio: surgery plus catumaxomab or surgery alone.
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus on day 0 and of four following ascending doses (10-20-50-150 µg) which will be administered as an i.p.-infusion via a provided indwelling catheter on the days 7, 10, 13 and 16, respectively.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-Label and Randomized Phase II Study to Evaluate Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients After Curative Resection of a Confirmed Gastric Adenocarcinoma Compared With Surgery Alone|
|Study Start Date :||July 2006|
|Actual Study Completion Date :||September 2007|
- safety and efficacy data
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): NCT00352833
|Hospital of Cologne-Merheim, Surgical Department|
|Cologne, Germany, 51109|
|Principal Investigator:||Marcus Heiss, Prof. Dr.||Cologne, Germany|