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

Tracking Information
First Received Date ^ICMJE	November 24, 2003
Last Updated Date	March 21, 2009
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00073541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Safety/Efficacy Study
Condition ^ICMJE	Ovarian Cancer
Intervention ^ICMJE	Drug: EMD 72000
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	September 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00073541
Responsible Party
Study ID Numbers ^ICMJE	EMD 72000-030
Study Sponsor ^ICMJE	EMD Serono
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	EMD Serono
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP