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

Last updated: October 2, 2012
Sponsor: Neovii Biotech
Overall Status: Completed

Phase

3

Condition

Neoplasms

Malignant Ascites

Carcinoma

Treatment

N/A

Clinical Study ID

NCT00822809
IP-CAT-AC-03
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

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 onlaboratory values and general status

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

Study Design

Total Participants: 230
Study Start date:
December 01, 2008
Estimated Completion Date:
April 30, 2011

Study Description

Safety data of the completed pivotal phase II/III trial, IP-REM-AC-01, in which catumaxomab was administered as 6 hour i.p. infusion showed that most reported AEs were cytokine release-related symptoms such as fever, nausea, and vomiting (based on the pharmacodynamic mode of action of catumaxomab) and abdominal pain. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the current trial was designed to determine whether tolerability of the 3 hour infusion of catumaxomab with and without premedication of prednisolone. Prednisolone was chosen as additional premedication with the objective to reduce cytokine release related symptoms which might change with the switch from 6 to 3 h infusion time.

Connect with a study center

  • Study Site

    Several,
    France

    Site Not Available

  • Study site

    Several,
    Germany

    Site Not Available

  • Study Site

    Several,
    Italy

    Site Not Available

  • Study Site

    Several,
    Spain

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.