Back to results

Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection

Primary Purpose

Gastric Cancer, Gastric Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Catumaxomab

catumaxomab

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, catumaxomab, neoadjuvant chemotherapy, phase II, interoperative, trifunctional antibody

Eligibility Criteria

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

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

catumaxomab arm

Arm Description

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.

Outcomes

Primary Outcome Measures

rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab

Secondary Outcome Measures

frequency, relationship and seriousness of adverse events

surgical resection rate

chemotherapeutic response rate

overall survival at 3, 6, 9, 12 and 24 month after EOT, defined as the time from study enrolment until death

disease-free survival at 3, 6, 9, 12 18 and 24 months after EOT, defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first

Full Information

NCT ID

NCT00464893

First Posted

April 23, 2007

Last Updated

December 3, 2013

Sponsor

Neovii Biotech

1. Study Identification

Unique Protocol Identification Number

NCT00464893

Brief Title

Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection

Official Title

Multicenter, Open-label Phase II Study to Evaluate the Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients With Gastric Adenocarcinoma After Neoadjuvant Chemotherapy and Intended Curative Resection

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neovii Biotech

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 subsequent to a neoadjuvant chemotherapy.

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 tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy. 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.

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, catumaxomab, neoadjuvant chemotherapy, phase II, interoperative, trifunctional antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

catumaxomab arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Catumaxomab

Other Intervention Name(s)

Removab

Intervention Description

10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16

Intervention Type

Drug

Intervention Name(s)

catumaxomab

Other Intervention Name(s)

Removab

Intervention Description

10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg

Primary Outcome Measure Information:

Title

rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab

Time Frame

30 days after last catumaxomab administration

Secondary Outcome Measure Information:

Title

frequency, relationship and seriousness of adverse events

Time Frame

30 days after last catumaxomab administration

Title

surgical resection rate

Time Frame

after surgery

Title

chemotherapeutic response rate

Time Frame

after neoadjuvant CTx

Title

overall survival at 3, 6, 9, 12 and 24 month after EOT, defined as the time from study enrolment until death

Time Frame

2 years

Title

disease-free survival at 3, 6, 9, 12 18 and 24 months after EOT, defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carsten Bokemeyer, Prof MD

Organizational Affiliation

University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany

Official's Role

Principal Investigator

Facility Information:

City

Innsbruck

Country

Austria

City

Hamburg, Berlin, Heidelberg, Köln, Halle

Country

Germany

City

Terrassa

Country

Spain

City

Nottingham

Country

United Kingdom

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

background

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

background

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

background

Learn more about this trial

Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection

We'll reach out to this number within 24 hrs