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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer, Gastric Adenocarcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety and efficacy data

Principal Investigator

Marcus Heiss, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cologne, Germany

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

IP-REM-GC-02

NCT ID:

NCT00352833

Start Date:

July 2006

Completion Date:

September 2007

Related Keywords:

  • Gastric Cancer
  • Gastric Adenocarcinoma
  • gastric cancer
  • investigational drug
  • adjuvant therapy
  • intraoperative
  • intraperitoneal
  • EpCAM-positive tumor
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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