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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neovii Biotech
ClinicalTrials.gov Identifier:
NCT00563836
First received: November 23, 2007
Last updated: October 2, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Ovarian Cancer
Epithelial Ovarian Cancer
Drug: Catumaxomab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Single-arm, Phase II Study of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intra- and Postoperatively in Patients With Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Neovii Biotech:

Primary Outcome Measures:
  • the rate of all specific postoperative complications newly observed during a period of 30 days after surgery [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety and efficacy endpoints [ Time Frame: EOS is on day 30, post study period additional 23 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 41
Study Start Date: November 2007
Study Completion Date: August 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Catumaxomab
10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16

Detailed Description:

An open label, multi-center, single-arm, phase II study according to Fleming´s one-stage design. The surgical procedure on Day 0 will be performed according to AGO State of the Art, followed by one intraoperative and four postoperative intraperitoneal administrations of catumaxomab within 16 days. The Discharge Visit will be performed when the patient is leaving the hospital but not earlier than 1 day after the last infustion, followed by the End of Study Visit on Day 30.

Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT00563836

Locations
Austria
Innsbruck, Austria
Germany
Klinikum Charité
Berlin, Germany, 13355
Sponsors and Collaborators
Neovii Biotech
Investigators
Principal Investigator: Jahlid Sehouli, MD Klinikum Charité, 13355 Berlin
  More Information

Publications:

Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT00563836     History of Changes
Other Study ID Numbers: IP-CAT-OC-02
Study First Received: November 23, 2007
Last Updated: October 2, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Neovii Biotech:
ovarian cancer
catumaxomab
phase II
intraoperative
adjuvant
trifunctional antibody

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Antibodies
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014