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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer, Neoplasms, Carcinoma, Malignant Ascites

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Florian Lordick, PD Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Med. Klinik III, Städtisches Klinikum Braunschweig gGmbH, Celler STr. 38, 38114 Braunschweig

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

IP-CAT-AC-03

NCT ID:

NCT00822809

Start Date:

December 2008

Completion Date:

April 2011

Related Keywords:

  • Cancer
  • Neoplasms
  • Carcinoma
  • Malignant Ascites
  • Cancer
  • Neoplasms
  • Carcinoma
  • Malignant Ascites
  • Drug therapy
  • Antineoplastic Protocols
  • Immunotherapy
  • Phase III
  • trifunctional antibody
  • monoclonal antibody
  • EpCAM
  • Ascites
  • Neoplasms
  • Carcinoma

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