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A study of the safety and effects of EMD 72000 in subjects with recurrent ovarian cancer



A study of the safety and effects of EMD 72000 in subjects with recurrent ovarian cancer

For Condition: Ovarian Cancer
Status: Recruiting
Sponsor(s): EMD Pharmaceuticals , Merck KGaA
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:  EMD 72000-030; 
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073541

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