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
Data Collection
Carcinoma, Ovarian Epithelial+16
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: April 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.38 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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