Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer

A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy

Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.

Inclusion Criteria:

• Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment.
• Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• All scans used to document complete response must be done within 30 days prior to randomization.
• Patients must be able to swallow and retain oral medication.

Exclusion Criteria:

• Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI).
• Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.
• Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
• Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.