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

This study has been completed.
Information provided by (Responsible Party):
Neovii Biotech Identifier:
First received: December 23, 2008
Last updated: October 2, 2012
Last verified: August 2012

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.

Condition Intervention Phase
Cancer Neoplasms Carcinoma Malignant Ascites Drug: Catumaxomab Drug: Prednisolone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two-arm, Randomized, Open-label, Phase IIIb Study Investigating the Safety of a 3 Hour i.p. Infusion of Catumaxomab With and Without Prednisolone Premedication in Patients With Malignant Ascites Due to Epithelial Cancer

Resource links provided by NLM:

Further study details as provided by Neovii Biotech:

Primary Outcome Measures:
  • Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score [ Time Frame: 6 months ]
  • Puncture-free survival defined as the time from clock start to first need for therapeutic ascites puncture or death, whichever occurs first. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Safety measured by • Incidence of all AEs, • Changes in clinically relevant laboratory values (hematology, clinical chemistry, coagulation, and urinalysis), • Physical examination, • Vital signs. [ Time Frame: 6 months ]
  • Time to next ascites puncture, number of ascites punctures until end of lifetime, overall survival, anti-cancer treatment [ Time Frame: 6 months ]
  • immune monitoring [ Time Frame: 6 months ]

Enrollment: 230
Study Start Date: December 2008
Study Completion Date: April 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

Patients will receive premedication of 25 mg (i.v.) prednisolone 30 minutes prior start of infusion of catumaxomab.

Catumaxomab will be infused i.p. with 3 hour constant rate infusions via an indwelling catheter.

Drug: Catumaxomab

Catumaxomab will be infused 4 times within 11 days as follows:

10 µg on day 0, 20 µg on day 3, 50 µg on day 7, 150 µg on day 10

Drug: Prednisolone
25 mg premedication
Catumaxomab will be administered in a dosage identical to Arm A but without the prednisolone premedication.
Drug: Catumaxomab

Catumaxomab will be infused 4 times within 11 days as follows:

10 µg on day 0, 20 µg on day 3, 50 µg on day 7, 150 µg on day 10

Detailed 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00822809

Study Site
Several, France
Study site
Several, Germany
Study Site
Several, Italy
Study Site
Several, Spain
Sponsors and Collaborators
Neovii Biotech
Principal Investigator: Florian Lordick, PD Dr. med. Med. Klinik III, Städtisches Klinikum Braunschweig gGmbH, Celler STr. 38, 38114 Braunschweig
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Neovii Biotech Identifier: NCT00822809     History of Changes
Other Study ID Numbers: IP-CAT-AC-03
Study First Received: December 23, 2008
Last Updated: October 2, 2012

Keywords provided by Neovii Biotech:
Malignant Ascites
Drug therapy
Antineoplastic Protocols
Phase III
trifunctional antibody
monoclonal antibody

Additional relevant MeSH terms:
Pathologic Processes
Antibodies, Bispecific
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents processed this record on September 20, 2017