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Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189345
First Posted: September 19, 2005
Last Update Posted: November 8, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AGO Study Group
  Purpose
Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Many patients respond to additional cytotoxic treatment with partial or complete responses, yet approximately 100% of these patients will ultimately progress. Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive option.EpCAM is expressed in a large number of epithelial ovarian cancer, fallopian tube or peritoneal cancer tissues. Thus targeting these cancers with an anti-EpCAM antibody is a promising innovative therapeutic approach.

Condition Intervention Phase
Ovarian Cancer Fallopian Tube Neoplasms Peritoneal Neoplasms Biological: anti-EpCAM x anti-CD3 (removab) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Primary Outcome Measures:
  • Selection of better dose level based on the confirmed tumor response.

Secondary Outcome Measures:
  • Evaluation of safety and tolerability
  • Effects of removab(TM)

Estimated Enrollment: 44
Study Start Date: May 2004
Estimated Study Completion Date: October 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

women 18 years and older histologically confirmed epithelial ovarian cancer, cancer of the fallopian tube or peritoneum measurable disease signed and dated informed consent one or two prior chemotherapies, the last platinum containing platinum refractory disease ECOG performance status 0-2

Exclusion Criteria:

acute or chronic infections previous treatment with mouse monoclonal antibodies known or suspected hypersensitivity to removab inadequate renal function inadequate hepatic function ileus cachectic patients

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189345


Locations
Germany
Dept. of Gynecology, University of Marburg
Marburg, Germany, 35037
Sponsors and Collaborators
AGO Study Group
Investigators
Principal Investigator: Uwe Wagner, Prof.Dr. AGO Study Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00189345     History of Changes
Other Study ID Numbers: AGO-OVAR 2.10
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: November 8, 2006
Last Verified: December 2003

Keywords provided by AGO Study Group:
Cancer
Cancer alternative therapies
ovarian cancer

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Antibodies
Muromonab-CD3
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents