MULTICENTER, OPEN-LABEL PHASE II STUDY TO EVALUATE THE EFFICACY OF A 2-CYCLE IMMUNOTHERAPY WITH THE TRI FUNCTIONAL BISPECIFIC ANTIBODY CATUMAXOMAB (ANTI EPCAM X ANTI-CD3) IN ADDITION TO SYSTEMIC CHEMOTHERAPY IN PATIENTS WITH PERITONEAL CARCINOMATOSIS FROM GASTRIC OR COLORECTAL ADENOCARCINOMA - PERCAT

Conditions: PERITONEAL CARCINOMATOSIS FROM GASTRIC OR COLORECTAL ADENOCARCINOMA
MedDRA version: 12.1Level: LLTClassification code 10068069Term: Peritoneal carcinomatosis
MedDRA version: 12.1Level: LLTClassification code 10052360Term: Colorectal adenocarcinoma
MedDRA version: 12.1Level: LLTClassification code 10017758Term: Gastric cancer

Registration Number: EUCTR2010-022810-26-DE

Lead Sponsor: niversity Witten/Herdecke

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

•Signed and dated informed consent
•Age ? 18 years
•Patient is suffering from EPCAM-positive peritoneal carcinoma-tosis of colorectal or gastric adenocarcinoma, which was con-firmed by histological analysis.
•ECOG status 1 or 2 (Karnofsky index ? 70)
•Patient is not eligible for surgical cytoreduction followed by hy-perthermic intraperitoneal chemotherapy (see Attachments for selection criteria).
•Patient is eligible for FOLFOX or FOLFIRI treatment in case of colorectal cancer; patient is eligible for FLO or FLOT treatment in case of gastric cancer (i.e. no intolerance or hypersensitivity, no tumor progression during treatment)
•Body mass index > 17
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Symptomatic ascites (estimated accumulation of more than 1500 ml by sonography and computer tomography and punc-ture of more than 1500 ml)
•Ileus or abdominal obstruction with the need of surgical inter-vention at inclusion or parenteral feeding (> 30% of daily calo-rie intake)
•Previous use of non-humanized monoclonal mouse or rat anti-bodies
•Known or suspected hypersensitivity or allergy to Catu-maxomab or to similar antibodies
•Presence of any acute or chronic systemic infection
•Pre-existing heart failure: NYHA class > II
•Pregnancy or breast feeding
•Other concurrent uncontrolled medical conditions
•Previous Catumaxomab therapy
•Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
•Inadequate renal function (Creatinine >1,5 x ULN)
•(PTT) Partial thromboplastine time > x ULN
•Inadequate hepatic function (AST or ALT > 2.5 x ULN or Bilirubin > 2 x ULN)
•Inadequate bone marrow function with platelets < 100 000 cells/mm3 or absolute neutrophil count (ANC) < 1500 cells/mm3 or a proportion of < 15% of lymphocytes in differential blood count
•Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method during the study and at least three months after the last infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
•Any further condition which, according to the investigator, re-sults in an undue risk to the patient during participation in the present study
•Parallel participation in another clinical trial
•Previous participation in the present study
•Treatment with another investigational product during this study or during the last 30 days prior to study start (day 0)