Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas

Inclusion Criteria:

* Histologically confirmed diagnosis of resectable gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction (type II and type III according to Siewerts classification)
* Macroscopic peritoneal carcinomatosis (stage P1-4 according to Gilly et al., appendix 1)
* Patients potentially eligible for gastrectomy after primary systemic (and intraperitoneal) treatment
* Signed and dated informed consent before the start of specific protocol procedures
* Age \> 18 years
* ECOG Performance Status of 0 or 1
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening

  * Hemoglobin \> 10.0 g/dl
  * Leukocyte count \> 4.000/μl; absolute neutrophil count (ANC) \> 2.000/μl
  * Platelet count \> = 100.000/µl
  * Total bilirubin \< 1,5 times the upper limit of normal
  * ALT and AST \< 3 x upper limit of normal
  * Alkaline phosphatase \< 5 x ULN
  * Serum creatinine \< 1.5 x upper limit of normal and creatinine clearance \> 60 ml/min
* The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations

Exclusion Criteria:

* Distant metastasis other than peritoneal seedings
* Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
* Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = \< 1 year before enrolment
* History of HIV infection or chronic hepatitis B or C
* Active, clinically serious infections (\> grade 2 NCI-CTC version 3.0)
* Pre-existing neuropathy \> grade 1 (NCI CTCAE), except for loss of tendon reflex
* Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
* History of organ allograft
* Patients undergoing renal dialysis
* Known hypersensitivity to any of the drugs given in the study; known hypersensitivity to murine (rat and/or mouse) proteins
* Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
* Excluded therapies and medications, previous and concomitant:

  * Prior anti-cancer chemotherapy or immunotherapy.
  * Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  * Major surgery within 4 weeks of starting the study, and patients must have recovered from effects of major surgery
* Pregnant or breast-feeding patients, or planning to become pregnant within 6 months after the end of treatment. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and for 6 months after the end of treatment
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's understanding of the informed consent procedure, participation in the study or evaluation of the study results