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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	Pharmaceutical / Industry	IP-CAT-AC-03 NCT00822809

Trial Description

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 156 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.

Further Study Information

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.

Efficacy variables will be measured as secondary endpoints to support the assumption that the efficacy of catumaxomab is not affected by premedication with prednisolone. Additionally, the trial will collect ascites-related symptoms and Quality of Life (QOL) data.

Eligibility 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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Fresenius AG

Florian Lordick

Principal Investigator

Volker Scherhammer, Dr.		Ph: +49-89-306593-17
		Email: clinicalstudies@fresenius-biotech.com

Germany
	Several
	Study site
		Contact Person	Ph: +49-89-30659317
			Email: clinicalstudies@fresenius-biotech.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00822809
Information obtained from ClinicalTrials.gov on March 18, 2009