Explorative Trial to Investigate Catumaxomab (Anti-EpCAM x Anti-CD3) for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas Prior to Gastrectomy
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