Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neovii Biotech
ClinicalTrials.gov Identifier:
NCT00822809
First received: December 23, 2008
Last updated: October 2, 2012
Last verified: August 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • Time to next ascites puncture, number of ascites punctures until end of lifetime, overall survival, anti-cancer treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • immune monitoring [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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
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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822809

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

Publications:
Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT00822809     History of Changes
Other Study ID Numbers: IP-CAT-AC-03
Study First Received: December 23, 2008
Last Updated: October 2, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Neovii Biotech:
Cancer
Neoplasms
Carcinoma
Malignant Ascites
Drug therapy
Antineoplastic Protocols
Immunotherapy
Phase III
trifunctional antibody
monoclonal antibody
EpCAM

Additional relevant MeSH terms:
Ascites
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Pathologic Processes
Antibodies, Bispecific
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 24, 2014