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

NCT ID: NCT00822809

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Cancer Neoplasms Carcinoma Malignant Ascites

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Catumaxomab

Intervention Type 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

Prednisolone

Intervention Type DRUG

25 mg premedication

B

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

Group Type OTHER

Catumaxomab

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Prednisolone

25 mg premedication

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neovii Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florian Lordick, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Study Site

Several, , France

Site Status

Study site

Several, , Germany

Site Status

Study Site

Several, , Italy

Site Status

Study Site

Several, , Spain

Site Status

Countries

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France Germany Italy Spain

References

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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.

Reference Type BACKGROUND
PMID: 18694358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17606723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18535935 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26049121 (View on PubMed)

Other Identifiers

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IP-CAT-AC-03

Identifier Type: -

Identifier Source: org_study_id