Peritoneal carcinomatosis from colorectal and gastric cancer (adenocarcinoma) Cancer Malignant neoplasm of colon
Conditions
Interventions
Investigational medicinal product: trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3)
Application of medicinal product: intraperitoneal (i.p.)
Intervention: Laparoscopy or laparotomy and exac
followed by another i.v.-chemotherapy between day 121 and day 180. Multimodal chemotherapy including biological modifiers (i.e. Cetuximab, Bevacizumab, Trastuzumab or others) is not permitted.
Sponsors
University of Witten/Herdecke (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged 18 years or older 2. Signed and dated informed consent 3. Patient has peritoneal carcinomatosis of colorectal or gastric adeno-carcinoma (histologically confirmed) 4. Eastern Cooperative Oncology Group (ECOG) status 1 or 2 (Karnofsky index >= 70)
Exclusion criteria
Exclusion criteria: 1. Symptomatic ascites (estimated accululation of more than 1500 ml by sonography and computer tomography and puncture of more than 1500 ml) 2. Ileus or abdominal obstruction with the need of surgical intervention at inclusion or parenteral feeding (> 30% of daily calorie intake) 3. Previous use of non-humanised monoclonal mouse or rat antibodies 4. Known or suspected hypersensitivity or allergy to catumaxomab or to similar antibodies 5. Presence of any acute or chronic systemic infection 6. Pre-existing heart failure > New York Heart Association (NYHA) class II 7. Pregnancy or breast feeding 8. Other concurrent uncontrolled medical conditions 9. Previous Catumaxomab therapy 10. Medical or psychiatric conditions that compromise the patient?s ability to give informed consent 11. Inadequate renal function (Creatinine > 1,5 x ULN) 12. Inadequate hepatic function (AST or ALT > 2.5 x ULN or Bilirubin > 2 x ULN) 13. 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 14. Pregnant or nursing woman, or woman of childbearing potential who is 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) 15. Any further condition which according to the investigator results in an undue risk to the patient during participation in the present study 16. Parallel participation in another clinical trial or previously in this study 17. Treatment with another investigational product during this study or during the last 30 days prior to study start (day 0) 18. Under no circumstances must a patient be enrolled in this study more than once
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Decrease of the incidence of clinically significant malignant ascites 2. Decrease of the Incidence of intestinal obstruction with the need of surgical intervention or parenteral nutrition 3. Decrease of the incidence of ECOG deterioration 4. Decrease of the incidence of death 5. Every parameter will be analysed separately in comparison to historical controls | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety parameters: 1.1. The need to discontinue catumaxomab infusion 1.2. Frequency, relationship and intensity of clinically relevant grade III and IV adverse events 2. Immunological monitoring: 2.1. Induction of anti-tumour response 2.2. Quality and quantity of epithelial cell adhesion molecule (EpCAM)-expression 2.3. Disseminated tumour cells and tumour stem cells within the peripheral blood during therapy 2.4. Anti-EpCAM and anti-HER2/neu humoral immune response 2.5. vascular endothelial growth factor (VEGF)-level during therapy 2.6. Induction of human anti-mouse antibodies (HAMA) 2.7. Systemic levels of catumaxomab after i.p. therapy | — |
Countries
Germany
Outcome results
None listed