Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer

NCT00563836 | Completed Phase 2 DMC

• 1 other identifier: IP-CAT-OC-02
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 2

Brief Summary

Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.

Conditions

Ovarian Cancer; Epithelial Ovarian Cancer

Keywords

ovarian cancer; catumaxomab; phase II; intraoperative; adjuvant; trifunctional antibody

Outcome Measures

Primary Outcomes (1)

• the rate of all specific postoperative complications newly observed during a period of 30 days after surgery

  30 days after surgery

Secondary Outcomes (1)

• safety and efficacy endpoints

  EOS is on day 30, post study period additional 23 months

Study Arms (1)

1

EXPERIMENTAL

Drug: Catumaxomab

Interventions

Catumaxomab DRUG

10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16

1

Eligibility Criteria

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

You may qualify if:

• signed and dated informed consent form before any protocol-specific screening procedures
• patients has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (FIGO IA(G2-G3) - IV)
• Karnofsky index \> or equal 70
• female at an age of 18 years or older
• negative pregnancy test

You may not qualify if:

• exposure to prior cancer therapy specific for ovarian cancer
• previos treatment with non-humanized mouse or rat monoclonal antibodies
• known / suspected hypersensitivity to catumaxomab or similar antibodies
• second malignangcy within the last 5 years
• presence of constant immunosuppressive therapy
• presence of symptomatic heart failure or occlusive arterial diseases
• inadequate renal or hepatic function
• presence of any acute or chronic systemic infection

Sponsors & Collaborators

• Neovii Biotech: lead

Study Sites (2)

Unknown Facility

Innsbruck, Austria

Location

Klinikum Charité

Berlin, 13355, Germany

Location

Related Publications (6)

• 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

• Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165.

  PMID: 15906359 BACKGROUND

• Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.

  PMID: 11410615 BACKGROUND

• Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.

  PMID: 10901380 BACKGROUND

• Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.

  PMID: 10415020 BACKGROUND

• Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.

  PMID: 11588051 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

catumaxomab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jahlid Sehouli, MD

  Klinikum Charité, 13355 Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2007
• First Posted: November 26, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: August 1, 2010
• Last Updated: October 3, 2012

Record last verified: 2012-08

Locations

DE (1); AU (1)