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
Collecte de données
Carcinome épithélial ovarien+16
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2003
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.38 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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