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

NCT00822809 | Completed Phase 3 DMC

• 1 other identifier: IP-CAT-AC-03
• Study Type: interventional
• Target: 230
• Locations: 4 countries
• Sites: 4

Brief 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 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.

Conditions

Cancer; Neoplasms; Carcinoma; Malignant Ascites

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  6 months

• Puncture-free survival defined as the time from clock start to first need for therapeutic ascites puncture or death, whichever occurs first.

  6 months

Secondary Outcomes (3)

• Safety measured by • Incidence of all AEs, • Changes in clinically relevant laboratory values (hematology, clinical chemistry, coagulation, and urinalysis), • Physical examination, • Vital signs.

  6 months

• Time to next ascites puncture, number of ascites punctures until end of lifetime, overall survival, anti-cancer treatment

  6 months

• immune monitoring

  6 months

Study Arms (2)

A

EXPERIMENTAL

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; Drug: Prednisolone

B

OTHER

Catumaxomab will be administered in a dosage identical to Arm A but without the prednisolone premedication.

Drug: Catumaxomab

Interventions

Catumaxomab DRUG

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

A; B

Prednisolone DRUG

25 mg premedication

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with malignant ascites requiring therapeutic ascites puncture
• Histological confirmed diagnosis of epithelial cancer
• Patients where standard therapy is not available or no longer feasible
• Karnofsky index ≥60 %
• Life expectancy \>12 weeks

You may not qualify if:

• Concomitant treatment with other investigational product, chemo-, or radiotherapy
• Recent exposure to an investigational product
• Known or suspected hypersensitivity to catumaxomab or similar antibodies
• Inadequate respiratory, renal or hepatic function
• Inadequate blood count (platelets, neutrophils)
• Required entirely parenteral nutrition
• Patients with ileus or subileus within the last 30 days
• Liver metastases with volume \>70 % of liver tissue
• Known portal vein obstruction
• Known Brain metastases
• Acute or chronic infection
• Not sufficiently recovered from previous treatment (toxicity present) based on laboratory values and general status
• Albumin lower than 3 g/dL or total protein \< 6g/dL

Sponsors & Collaborators

• Neovii Biotech: lead

Study Sites (4)

Study Site

Several, France

Location

Study site

Several, Germany

Location

Study Site

Several, Italy

Location

Study Site

Several, Spain

Location

Related Publications (4)

• Lordick F, Ott K, Weitz J, Jager D. The evolving role of catumaxomab in gastric cancer. Expert Opin Biol Ther. 2008 Sep;8(9):1407-15. doi: 10.1517/14712598.8.9.1407.

  PMID: 18694358 BACKGROUND

• Burges A, Wimberger P, Kumper C, Gorbounova V, Sommer H, Schmalfeldt B, Pfisterer J, Lichinitser M, Makhson A, Moiseyenko V, Lahr A, Schulze E, Jager M, Strohlein MA, Heiss MM, Gottwald T, Lindhofer H, Kimmig R. Effective relief of malignant ascites in patients with advanced ovarian cancer by a trifunctional anti-EpCAM x anti-CD3 antibody: a phase I/II study. Clin Cancer Res. 2007 Jul 1;13(13):3899-905. doi: 10.1158/1078-0432.CCR-06-2769.

  PMID: 17606723 BACKGROUND

• Shen J, Zhu Z. Catumaxomab, a rat/murine hybrid trifunctional bispecific monoclonal antibody for the treatment of cancer. Curr Opin Mol Ther. 2008 Jun;10(3):273-84.

  PMID: 18535935 BACKGROUND

• Fossati M, Buzzonetti A, Monego G, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological changes in the ascites of cancer patients after intraperitoneal administration of the bispecific antibody catumaxomab (anti-EpCAMxanti-CD3). Gynecol Oncol. 2015 Aug;138(2):343-51. doi: 10.1016/j.ygyno.2015.06.003. Epub 2015 Jun 3.

  PMID: 26049121 DERIVED

MeSH Terms

Conditions

Neoplasms; Carcinoma

Interventions

catumaxomab; Prednisolone

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Florian Lordick, PD Dr. med.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: January 14, 2009
• Study Start: December 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: April 1, 2011
• Last Updated: October 3, 2012

Record last verified: 2012-08

Locations

DE (1); IT (1); FR (1); ES (1)