Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection
NCT ID: NCT00464893
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2007-04-30
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Catumaxomab
10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
catumaxomab
10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg
Interventions
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Catumaxomab
10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
catumaxomab
10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Neovii Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Carsten Bokemeyer, Prof MD
Role: PRINCIPAL_INVESTIGATOR
University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany
Locations
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Innsbruck, , Austria
Hamburg, Berlin, Heidelberg, Köln, Halle, , Germany
Terrassa, , Spain
Nottingham, , United Kingdom
Countries
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References
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Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165.
Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.
Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.
Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.
Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.
Other Identifiers
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EudraCT-Nr.:2006-002727-16
Identifier Type: -
Identifier Source: secondary_id
IP-CAT-GC-03
Identifier Type: -
Identifier Source: org_study_id