Status:
COMPLETED
Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection
Lead Sponsor:
Neovii Biotech
Conditions:
Gastric Cancer
Gastric Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subs...
Detailed Description
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...
Eligibility Criteria
Inclusion
- signed and dated informed consent
- male or female patient at an age of 18 years or older
- patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
- TNM-staging at screening of T3/T4, N+/-, M0 or T2, N+, M0
- indication and eligibility for a neoadjuvant chemotherapeutic regimen featuring three cycles of ECX with 21 days per cycle
- intended curative gastrectomy
- Karnofsky index \> 70
Exclusion
- Exposure to prior cancer therapy or planned adjuvant chemo- or radiotherapy of the current gastric cancer
- prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
- previous use of non-humanized monoclonal mouse or rat antibodies
- treatment with another investigational product during this study or during the last 30 days prior to study start
- presence of distant metastases
- presence of constant immunosuppressive therapy
- history of pancreas resection (also partial) or thoracotomy
- presence of any acute or chronic systemic infection
- patient with a bowel obstruction within the last 30 days
- known contraindications to any of the planned ECX chemotherapeutics
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00464893
Start Date
April 1 2007
End Date
April 1 2013
Last Update
December 4 2013
Active Locations (4)
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1
Innsbruck, Austria
2
Hamburg, Berlin, Heidelberg, Köln, Halle, Germany
3
Terrassa, Spain
4
Nottingham, United Kingdom