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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neovii Biotech
ClinicalTrials.gov Identifier:
NCT00464893
First received: April 23, 2007
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Gastric Adenocarcinoma
Drug: Catumaxomab
Drug: catumaxomab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Neovii Biotech:

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 [ Time Frame: 30 days after last catumaxomab administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • frequency, relationship and seriousness of adverse events [ Time Frame: 30 days after last catumaxomab administration ] [ Designated as safety issue: Yes ]
  • surgical resection rate [ Time Frame: after surgery ] [ Designated as safety issue: No ]
  • chemotherapeutic response rate [ Time Frame: after neoadjuvant CTx ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: April 2007
Study Completion Date: April 2013
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Catumaxomab
10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
Other Name: Removab
Drug: catumaxomab
10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg
Other Name: Removab

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464893

Locations
Austria
Innsbruck, Austria
Germany
Hamburg, Berlin, Heidelberg, Köln, Halle, Germany
Spain
Terrassa, Spain
United Kingdom
Nottingham, United Kingdom
Sponsors and Collaborators
Neovii Biotech
Investigators
Principal Investigator: Carsten Bokemeyer, Prof MD University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany
  More Information

Publications:
Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT00464893     History of Changes
Other Study ID Numbers: IP-CAT-GC-03, EudraCT-Nr.:2006-002727-16
Study First Received: April 23, 2007
Last Updated: December 3, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Neovii Biotech:
gastric cancer
catumaxomab
neoadjuvant chemotherapy
phase II
interoperative
trifunctional antibody

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014