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

This study has been completed.

First Received: November 24, 2003 Last Updated: March 21, 2009 History of Changes

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00073541

Purpose

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	Intervention	Phase
Ovarian Cancer	Drug: EMD 72000	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by EMD Serono:

Estimated Study Completion Date:

September 2004

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073541

Locations

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

More Information

No publications provided

Study ID Numbers:	EMD 72000-030
Study First Received:	November 24, 2003
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00073541 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by EMD Serono:

EGFR; HER-1; monoclonal antibody; targeted therapy

Study placed in the following topic categories:

Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Recurrence

Genital Diseases, Female
Antibodies, Monoclonal
Antibodies
Ovarian Cancer
Endocrinopathy
Immunoglobulins
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009