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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer, Gastric Adenocarcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

30 days after last catumaxomab administration

Safety Issue:

Yes

Principal Investigator

Carsten Bokemeyer, Prof MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

IP-CAT-GC-03

NCT ID:

NCT00464893

Start Date:

April 2007

Completion Date:

July 2013

Related Keywords:

  • Gastric Cancer
  • Gastric Adenocarcinoma
  • gastric cancer
  • catumaxomab
  • neoadjuvant chemotherapy
  • phase II
  • interoperative
  • trifunctional antibody
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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