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A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer

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. Identifier: NCT00073541
Recruitment Status : Completed
First Posted : November 26, 2003
Last Update Posted : January 20, 2017
Information provided by:
EMD Serono

Brief Summary:
EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: EMD 72000 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase II Study in Subjects With Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent
Study Start Date : April 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease
  • Immunohistochemical evidence of tumor EGFR (HER-1) expression
  • At least one measurable lesion according to the WHO criteria
  • Life expectancy ≥ 12 weeks
  • ECOG performance status 0-1

Exclusion Criteria:

  • History of prior MAb therapy
  • History of prior treatment with an EGFR (HER-1) directed therapy
  • Known brain metastases
  • Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted)
  • Known intercurrent infections or immunosuppression
  • Actively infected with, or chronic carriers of HBV
  • Evidence of HCV disease
  • Previous diagnosis of autoimmune disease
  • Known hypersensitivity to the administered drugs or any of their components
  • Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment

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 identifier (NCT number): NCT00073541

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United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New York
New York, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
Sponsors and Collaborators
EMD Serono

Publications of Results:
Layout table for additonal information Identifier: NCT00073541     History of Changes
Other Study ID Numbers: EMD 72000-030
First Posted: November 26, 2003    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by EMD Serono:
EGFR; HER-1; monoclonal antibody; targeted therapy

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type