Overview

CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized phase IIIb study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated. A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Neovii Biotech
Treatments:
Antibodies
Antibodies, Bispecific
Catumaxomab
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Key Inclusion Criteria:

1. Patients with malignant ascites requiring therapeutic ascites puncture

2. Histological confirmed diagnosis of epithelial cancer

3. Patients where standard therapy is not available or no longer feasible

4. Karnofsky index ≥60 %

5. Life expectancy >12 weeks

Key Exclusion Criteria:

1. Concomitant treatment with other investigational product, chemo-, or radiotherapy

2. Recent exposure to an investigational product

3. Known or suspected hypersensitivity to catumaxomab or similar antibodies

4. Inadequate respiratory, renal or hepatic function

5. Inadequate blood count (platelets, neutrophils)

6. Required entirely parenteral nutrition

7. Patients with ileus or subileus within the last 30 days

8. Liver metastases with volume >70 % of liver tissue

9. Known portal vein obstruction

10. Known Brain metastases

11. Acute or chronic infection

12. Not sufficiently recovered from previous treatment (toxicity present) based on
laboratory values and general status

13. Albumin lower than 3 g/dL or total protein < 6g/dL