PERITONEAL CARCINOMATOSIS FROM GASTRIC OR COLORECTAL ADENOCARCINOMA MedDRA version: 12.1 Level: LLT Classification code 10068069 Term: Peritoneal carcinomatosis MedDRA version: 12.1 Level: LLT Classification code 10052360 Term: Colorectal adenocarcinoma MedDRA version: 12.1 Level: LLT Classification code 10017758 Term: Gastric cancer
Conditions
Interventions
Trade Name: Removab (Catumaxomab)
Product Name: Removab
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Catumaxomab
CAS Number: 509077-98-9
Other descripti
Sponsors
University Witten/Herdecke
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Decrease of the incidence of clinically significant malignant ascites (defined by one paracentesis of > 1500 ml or a cumulative amount of 1500 ml by multiple paracentesis within 10 days) from 40% (estimated value from the literature) to 15% within 9 months after first catumaxomab therapy. The event will be counted on the day of 2nd paracentesis •Decrease of the incidence of intestinal obstruction with the indication of surgery or parenteral nutrition (> 14 days, > 70% of calorie intake) from to 40% (estimated value from literature and local database) to 20 % within 9 months after first Catumaxomab therapy •Decrease of the incidence of ECOG deterioration from ECOG 1 or 2 to ECOG 3 in within 9 months after first Catumaxomab therapy •decrease of the incidence of death from 60 % to 35% within 9 months after first Catumaxomab therapy ;Secondary Objective: Safety endpoints: -medical incidence to terminate catumaxomab infusion -Frequency, relationship and intensity of clinically relevant grade III and IV adverse events (AEs) Immunological endpoints: -Quality and Quantity of EpCAM-expression on PC samples -Incidence and quality of EpCAM positive Tumor cells in intraperitoneal lavage specimen -Disseminated tumor cells and tumor stem cells in peripheral blood during therapy -Proportion and absolute numbers of leukocytes (T-cells, B-cells, NK cells, macrophages) in peripheral blood -Anti-EpCAM and anti-HER2/neu humoral immune response -VEGF levels during therapy -Induction of human anti-mouse antibodies (HAMA) -Pharmakokinetics: Systemic levels of catumaxomab after i.p. therapy - -Blood samples and tissue samples will be asservated for future anaylsis. Informed consent for storage of the samples will be mandatorily obtained from every involved patient. ;Primary end point(s): Symptom- and progression free survival, defined by the primary end-points: •Incidence of clinically significant malignant ascites (defined by one paracentesis of > 1500 ml or a cumu | — |
Countries
Germany
Outcome results
None listed