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

Primary Purpose

Cancer, Neoplasms, Carcinoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Catumaxomab

Prednisolone

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Neoplasms, Carcinoma, Malignant Ascites, Drug therapy, Antineoplastic Protocols, Immunotherapy, Phase III, trifunctional antibody, monoclonal antibody, EpCAM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Sites / Locations

Study Site
Study site
Study Site
Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

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

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

immune monitoring

Full Information

NCT ID

NCT00822809

First Posted

December 23, 2008

Last Updated

October 2, 2012

Sponsor

Neovii Biotech

1. Study Identification

Unique Protocol Identification Number

NCT00822809

Brief Title

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

Acronym

CASIMAS

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neovii Biotech

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Neoplasms, Carcinoma, Malignant Ascites

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Catumaxomab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Prednisolone

Intervention Description

25 mg premedication

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

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 Measure Information:

Title

Time Frame

6 months

Title

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

Time Frame

6 months

Title

immune monitoring

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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 Key Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florian Lordick, PD Dr. med.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Study Site

City

Several

Country

France

Facility Name

Study site

City

Several

Country

Germany

Facility Name

Study Site

City

Several

Country

Italy

Facility Name

Study Site

City

Several

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

18694358

Citation

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.

Results Reference

background

PubMed Identifier

17606723

Citation

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.

Results Reference

background

PubMed Identifier

18535935

Citation

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.

Results Reference

background

PubMed Identifier

26049121

Citation

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.

Results Reference

derived

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

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