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Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma

Primary Purpose

Gastric Cancer, Gastric Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
catumaxomab
Sponsored by
Neovii Biotech
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, investigational drug, adjuvant therapy, intraoperative, intraperitoneal, EpCAM-positive tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed and dated informed consent Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3) Intended curative gastrectomy ('en-bloc´-R0-resection considering the standard D2-scheme) Serosal infiltration (T3/T4, N+/-, M0) confirmed by immediate section with histopathologic assessment during surgery Karnofsky index >= 70 Negative pregnancy blood test at screening in women with childbearing potential Exclusion Criteria: Presence of distant metastases Macroscopic and microscopic residual tumor present after surgery State after pancreas resection or thoracotomy Exposure to prior cancer therapy or planned adjuvant chemo-or radiotherapy of the current gastric cancer Previous treatment with non-humanized mouse or rat monoclonal antibodies Known/suspected hypersensitivity to catumaxomab or similar antibodies Any cancer disease or any cancer treatments within the last 5 years Presence of constant immunosuppressive therapy Inadequate renal function (creatinine > 1.5 x ULN) Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin >= 1.5 x ULN) Platelets < 75000 cells/mm³; absolute neutrophil count < 1500 cells/mm³ Patient had a bowel obstruction within the last 30 days Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms) Presence of any acute or chronic systemic infection Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study Patient is an employee of any involved study investigator or any involved institution including the study sponsor Parallel participation in another clinical trial or previous participation in this study Treatment with another investigational product during this study or during the last 30 days prior to study start

Sites / Locations

  • Hospital of Cologne-Merheim, Surgical Department

Outcomes

Primary Outcome Measures

safety and efficacy data

Secondary Outcome Measures

Full Information

First Posted
July 14, 2006
Last Updated
October 25, 2007
Sponsor
Neovii Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT00352833
Brief Title
Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neovii Biotech

4. Oversight

5. Study Description

Brief Summary
Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety, tolerability and feasibility and secondary on relevant efficacy parameters.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastric Adenocarcinoma
Keywords
gastric cancer, investigational drug, adjuvant therapy, intraoperative, intraperitoneal, EpCAM-positive tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
catumaxomab
Primary Outcome Measure Information:
Title
safety and efficacy data

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated informed consent Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3) Intended curative gastrectomy ('en-bloc´-R0-resection considering the standard D2-scheme) Serosal infiltration (T3/T4, N+/-, M0) confirmed by immediate section with histopathologic assessment during surgery Karnofsky index >= 70 Negative pregnancy blood test at screening in women with childbearing potential Exclusion Criteria: Presence of distant metastases Macroscopic and microscopic residual tumor present after surgery State after pancreas resection or thoracotomy Exposure to prior cancer therapy or planned adjuvant chemo-or radiotherapy of the current gastric cancer Previous treatment with non-humanized mouse or rat monoclonal antibodies Known/suspected hypersensitivity to catumaxomab or similar antibodies Any cancer disease or any cancer treatments within the last 5 years Presence of constant immunosuppressive therapy Inadequate renal function (creatinine > 1.5 x ULN) Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin >= 1.5 x ULN) Platelets < 75000 cells/mm³; absolute neutrophil count < 1500 cells/mm³ Patient had a bowel obstruction within the last 30 days Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms) Presence of any acute or chronic systemic infection Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study Patient is an employee of any involved study investigator or any involved institution including the study sponsor Parallel participation in another clinical trial or previous participation in this study Treatment with another investigational product during this study or during the last 30 days prior to study start
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Heiss, Prof. Dr.
Organizational Affiliation
Cologne, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Cologne-Merheim, Surgical Department
City
Cologne
ZIP/Postal Code
51109
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15906359
Citation
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.
Results Reference
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PubMed Identifier
11588051
Citation
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.
Results Reference
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PubMed Identifier
11410615
Citation
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.
Results Reference
background
PubMed Identifier
10901380
Citation
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.
Results Reference
background
PubMed Identifier
10415020
Citation
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.
Results Reference
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Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma

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