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