A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer - Full Text View

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

This study has been completed.

Sponsors and Collaborators:	EMD Pharmaceuticals Merck KGaA
Information provided by:	EMD Pharmaceuticals
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

MedlinePlus related topics:

Cancer Ovarian Cancer

U.S. FDA Resources

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

Further study details as provided by EMD Pharmaceuticals:

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 Pharmaceuticals

Merck KGaA

More Information

Study ID Numbers:	EMD 72000-030
First Received:	November 24, 2003
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00073541
Health Authority:	United States: Food and Drug Administration

Keywords provided by EMD Pharmaceuticals:

EGFR; HER-1; monoclonal antibody; targeted therapy

Study placed in the following topic categories:

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Ovarian Diseases

Recurrence

Genital Diseases, Female

Antibodies, Monoclonal

Antibodies

Endocrinopathy

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008