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

October 2, 2012 updated by: Neovii Biotech

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Several, France
        • Study Site
  • Germany
      • Several, Germany
        • Study Site
  • Italy
      • Several, Italy
        • Study Site
  • Spain
      • Several, Spain
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: B
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score
Time Frame: 6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months
Time to next ascites puncture, number of ascites punctures until end of lifetime, overall survival, anti-cancer treatment
Time Frame: 6 months
6 months
immune monitoring
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neovii Biotech

Investigators

  • Principal Investigator: Florian Lordick, PD Dr. med., Med. Klinik III, Städtisches Klinikum Braunschweig gGmbH, Celler STr. 38, 38114 Braunschweig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 23, 2008

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP-CAT-AC-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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