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

October 25, 2007 updated by: Neovii Biotech

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 51109
        • Hospital of Cologne-Merheim, Surgical Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
safety and efficacy data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neovii Biotech

Investigators

  • Principal Investigator: Marcus Heiss, Prof. Dr., Cologne, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

July 14, 2006

First Submitted That Met QC Criteria

July 14, 2006

First Posted (Estimate)

July 17, 2006

Study Record Updates

Last Update Posted (Estimate)

October 26, 2007

Last Update Submitted That Met QC Criteria

October 25, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP-REM-GC-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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